MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 22MM; SCREW, FIXATION, BONE

Catalog Number 212.822

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient information not available for reporting.Date of device migration is not known.The 510k: this report is for two (2) unknown va locking screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.Date of implant/explant is not known complainant part is not expected to be returned for manufacturer review/investigation.Facility telephone not available for reporting.Initial reporter is synthes sales consultant.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes europe reports an event in the (b)(6) as follows: it was reported patient was implanted with a variable angle (va) distal radius plate and unknown quantity of va locking screws on unknown date.On unknown date it was revealed that two (2) of the va locking screws have backed out.Surgeon states the incorrect drill guide was used and the screws were outside the 15 degree parameter.Patient was returned to surgery on unknown date where the plate and screws were removed.Concomitant device reported: distal radius plate (part number unknown, lot number unknown, quantity 1).This report is for two (2) unknown va locking screws.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Brand name: product name is now known.Product catalog and udi is now known.Common devicename: additional procode: hrs.Report source: physical manufacturer is now known.Product 510(k) is now known.Code 3191 used to capture required surgical intervention and device removal.Investigation site: cq zuchwil; selected flow: 7.Adverse event (no reported product problem).This flow was chosen as there is no allegation against the screws from the user as he is aware that an incorrect drill guide was used.Visual inspection: the received locking screws are, on the first sight, in a good condition.This is also confirmed by the fact that locking of the screw head in the hole of the also received plate is still possible.However, the microscopic inspection has shown that the last thread flank at the shaft and the first thread flank at the head are slightly damaged.These damages are an indication for a contact with the plate below the head and are a sign of an excessive insertion angle.Summary: the complaint condition is not confirmed as the screws can still be locked in the plate as required.The evaluation has shown that all received seven screws are from the part family 212.8xx.The two screws, which became loose have the part number 212.822.Therefore, it can be concluded that all received screws are 2.4 locking screws without variable angle (va) function.The complaint description states that the va locking screws were inserted out of the 15° angle of the variable angle lcp two-column volar distal radius plate as an incorrect drill sleeve was used.In this relation, the following statement for the surgical technique can be mentioned: to ensure that the screw is locked correctly, do not angle it in excess of +/¿15° from the nominal trajectory of the hole.However, the statement above is for va locking screws and the evaluation has shown that the returned screws are 2.4 locking screws without the rounded va head.Therefore, the statement below the 2.4 locking screws on page 32 from the same surgical technique is relevant in this case: for use in va locking holes but only in predefined angle using nominal angle technique.Based on the complaint description, which states that the 15° angle was exceeded, it can be assumed that the received 2.4 locking screw were not inserted in the predefined angle by using nominal angle technique and that the screws were therefore not locked in the plate as designed.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Concomitant devices: 2.4/2.7 va-lcp 2-c drp std 6h hd/7h shaft/109mm/lt-ster (part: 02.111.671s, lot: l275303, quantity: 1), 2.4mm locking screw slf-tpng with stardrive recess 14mm (part: 212.814, lot: unknown, quantity: 3), 2.4mm locking screw slf-tpng with stardrive recess 22mm (part: 212.822, lot: unknown, quantity: 1), 2.4mm locking screw slf-tpng with stardrive recess 20mm (part: 212.820, lot: unknown, quantity: 1).This report is for a 2.4mm locking screw slf-tpng with stardrive recess 22mm.This is report 1 of 3 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Customer quality investigation of the returned device and provided x-rays has been updated.Investigation site: cq zuchwil selected flow: 7.Adverse event (no reported product problem).This flow was chosen as there is no allegation against the screws from the user as he is aware that an incorrect drill guide was used.Visual inspection: the received locking screws are on the first sight in a good condition.This is also confirmed by the fact that locking of the screw head in the hole of the also received plate is still possible.However, the microscopic inspection has shown that the last thread flank at the shaft and the first thread flank at the head are slightly damaged.These damages are an indication for a contact with the plate below the head and are a sign of an excessive insertion angle.Summary: the complaint condition is not confirmed as the screws can still be locked in the plate as required.The evaluation has shown that all received seven screws are from the part family 212.8xx.The two screws, which became loose have the part number 212.822.Therefore is can be concluded that all received screws are 2.4 locking screws without variable angle (va) function.The complaint description states that the va locking screws were inserted out of the 15° angle of the variable angle lcp two-column volar distal radius plate as an incorrect drill sleeve was used.In this relation following statement for the surgical technique can be mentioned: to ensure that the screw is locked correctly, do not angle it in excess of +/¿15° from the nominal trajectory of the hole.However, the statement above is for va locking screws and the evaluation has shown that the returned screws are 2.4 locking screws without the rounded va head.Therefore the statement below the 2.4 locking screws from the same surgical technique is relevant in this case: for use in va locking holes but only in predefined angle using nominal angle technique.Based on the complaint description, which states that the 15° angle was exceeded, it can be assumed that the received 2.4 locking screw were not inserted in the predefined angle by using nominal angle technique and that the screws were therefore not locked in the plate as designed.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.The received x-rays were reviewed and there are two backed out locking screws visible.Based on these pictures the complaint condition can be confirmed and the disposition will be updated from unconfirmed to confirmed.The investigation itself will not be updated as the x-rays have no influence on the investigation result of the received material.H11 corrected data: b5: event description device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes europe reports an event in the united kingdom as follows: it was reported patient was implanted with a variable angle (va) distal radius plate and unknown quantity of va locking screws on unknown date.On unknown date it was revealed that two (2) of the va locking screws have backed out.Surgeon states the incorrect drill guide was used and the screws were outside the 15 degree parameter.Patient was returned to surgery on unknown date where the plate and screws were removed.Patient was revised to a competitor¿s plate.Concomitant devices reported: 2.4/2.7 va-lcp 2 column distal radius plate (part: 02.111.671s, lot: l275303, quantity: 1), 2.4mm locking screw self tapping with stardrive recess 14mm (part: 212.814, lot: unknown, quantity: 3), 2.4mm locking screw self tapping with stardrive recess 22mm (part: 212.822, lot: unknown, quantity: 1), 2.4mm locking screw self tapping with stardrive recess 20mm (part: 212.820, lot: unknown, quantity: 1).

• Brand Name: 2.4MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 22MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7558627
• MDR Text Key: 109747992
• Report Number: 8030965-2018-54070
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K103243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 212.822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Date Manufacturer Received: 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention