MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM TI VA LOCKING SCREW STARDRIVE 14MM-STERILE; PLATE, FIXATION, BONE

Catalog Number 04.210.114S

Device Problem Device Difficult to Maintain (3134)

Patient Problem No Code Available (3191)

Event Date 10/17/2018

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.

Event Description

It was reported that on (b)(6) 2018 an open reduction internal fixation (orif) was applied for distal radius fracture.During the surgery, a variable angle (va) locking screw was in question upon passing through a locking compression plate (lcp) which was as well in question without lock on the hole of the said plate.The detail situation of the surgery was as follows. after the surgeon fixed the distal part of the affected plate on the bone, the surgeon inserted one (1) cortical screw and two (2) locking screws into holes on the plate shaft for adjusting compression and tilt condition of the plate.When the surgeon checked images, it was found that there was a gap between the plate and the distal area of the bone. then the surgeon loosen the four (4) locking screws which had been inserted at the most distal part of the plate, then, re-adjusted the position of the plate, inserted two (2) screws into the second distal holes.Then, the surgeon re-inserted the four (4) screws at the most distal holes.When the surgeon removed the guiding block from the plate for fastening all the screws, the surgeon could not see the head of the screw which had been inserted at the most distal hole on the radius side.The surgeon checked images again and found that the affected screw had passed through the hole without lock on the hole. the surgeon advanced the affected screw then made an additional incision at the posterior side and removed the screw through it. procedure was completed, however with a 30 minutes delay reported.It was unknown if there were adverse event to the patient.This complaint is for one (1) 2.4mm ti va locking screw stardrive 14mm-sterile concomitant device reported: cortical screw (part#unknown, lot#unknown, quantity#1) locking screw (part#unknown, lot#unknown, quantity#2) this complaint involves (2) devices.This report is 2 of 2 for (b)(4).

Event Description

Further it was reported that the procedure was completed with no other screw was inserted through the affected hole and it was left open.

Manufacturer Narrative

The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.Additional narrative: initial reporter name and address: additional information provided.Please note, this dhr review is for sterilization procedure only: part: 04.210.114s; lot: l962121; manufacturing location: selzach; supplier: frueh ag; release to warehouse date: july 05, 2018; expiry date: june 01, 2028 non-sterile 04.210.114 / h643581 was manufactured in us, monument manufacturing date: may 1, 2018; part: 04.210.114; 2.4mm ti va locking screw stardrive 14mm; lot: h643581 (non-sterile) ; lot quantity: 238.Work order traveler met all inspection acceptance criteria.Inspection sheet, mill shaft thread / head thread / flute met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Component part(s) reviewed: part: 04.210.106.999; 2.8mm ti screw blank 14mm 02.7 variable angle w/sds; lot: h571851; lot quantity: 916.Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process dimensional met all inspection acceptance criteria.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Investigation site: zuchwil; selected flow(s): 2.Device interaction/functional visual inspection: the visual inspection shows traces of use at the screw head.Functional test / dimensional inspection: a functional test was performed with a test plate.The screw could be inserted into the test plate without any problems and did not pass through the screw hole.In addition, the dimensions were checked at the time of manufacturing with no issues documented.Document/ specification review: the device history record shows this lot (non-sterile) was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.Summary: the received condition of the device is not concordant with the complaint description and the complaint condition is not confirmed.A function test was performed with a test plate without any problems.We assume that an incorrect screwdriver was used with too much force applied.It is recommended to use the screwdriver according to the surgical technique.The applicable risk management document was reviewed and found to adequately address this complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Corrected data: reporter last name.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.

• Brand Name: 2.4MM TI VA LOCKING SCREW STARDRIVE 14MM-STERILE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8030434
• MDR Text Key: 125907210
• Report Number: 8030965-2018-57829
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819980648
• UDI-Public: (01)07611819980648
• Combination Product (y/n): N
• PMA/PMN Number: K102694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.210.114S
• Device Lot Number: L962121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Date Manufacturer Received: 12/17/2018
• Patient Sequence Number: 1
• Treatment: SEE EVENT DESCRIPTION.
• Patient Outcome(s): Required Intervention