MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH STARDRIVE SCREWDRIVER SHAFT T15/SELF-RETAINING QC; SCREWDRIVERS

Catalog Number 03.614.019

Device Problems Material Twisted/Bent (2981); Naturally Worn (2988); Device Difficult to Maintain (3134)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

Device history: manufacturing location: supplier ¿ (b)(4) / inspected, packaged and released by: (b)(4).Release date: 22-jul-2008.Part number: 03.614.019, stardrive screwdriver shaft t15/self-retaining qc.Lot number: 5768853 (non-sterile).Lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, incoming / final inspection met all inspection acceptance criteria.Certificate of compliance received from universal punch corp.Dated 09-jul-2008 was reviewed sand determined to be conforming.Packaging label log was reviewed and determined to be conforming.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Device history batch null, device history review 27-nov-2018: dhr reviewed this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.The device was received, the investigation summary: complaint description: it was reported that a patient underwent an unknown surgery on (b)(6) 2018, during the procedure, two (2) stardrive screwdriver shaft was unable to retain the screw when the surgeon inserted the setscrew.There was a surgery delay of less than 30 minutes.There was no adverse consequence to the patient.Procedure outcome is unknown.Flow: visual (appearance not as expected) and device interaction/functional.Visual inspection: the returned device was examined, and the distal tip was found to be stripped.The observed damage is consistent with the reported complaint condition as such the complaint condition can be confirmed.No further visual defects or deficiencies were noted.Functional inspection: no functional inspection was able to be completed as the mating screws in question were not returned.The observed stripped condition of the distal tip is consistent with the allegation of will not hold.Conclusion: after a visual inspection per guidance, it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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

It was reported that a patient underwent an unknown surgery on (b)(6) 2018, during the procedure, two (2) stardrive screwdriver shaft was unable to retain the screw when the surgeon inserted the setscrew.There was a surgery delay of less than 30 minutes.There was no adverse consequence to the patient.Procedure outcome is unknown.Concomitant device reported: unknown screw (part number unknown, lot number unknown, quantity unknown).This complaint involves two (2) devices.This report is 2 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional information provided.Reporter is a synthes employee.Device codes, patient codes 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: STARDRIVE SCREWDRIVER SHAFT T15/SELF-RETAINING QC
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8272190
• MDR Text Key: 133932815
• Report Number: 8030965-2019-60234
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 07611819968646
• UDI-Public: (01)07611819968646
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.614.019
• Device Lot Number: 5768853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/23/2019
• Supplement Dates Manufacturer Received: 01/27/2019
• Supplement Dates FDA Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1