MAUDE Adverse Event Report: SYNTHES GMBH CANNULATED CRUCIFORM SCREWDRIVER; SCREWDRIVERS.

Catalog Number	314.463
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j representative.The investigation could not be completed, no product was received; 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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for the cannulated cancellous screw removal surgery for the patella.The surgery was completed successfully.During the surgery, the screwdriver tip was missing and unable to remove the screw.The surgery was completed successfully within 30 minutes delay.No further information is available.This complaint involves one (1) device.This report is for (1) cannulated cruciform screwdriver.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.The product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that va scrdriver-crucif-cann f/cannscr ø3 was broken at the tip two pieces of the cruciform part of the screwdriver was broken and no other issues were identified.The dimensional inspection was not performed due to the post manufacturing damage.The observed condition of scrdriver-crucif-cann f/cannscr ø3 in the device was consistent.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for scrdriver-crucif-cann f/cannscr ø3.While no definitive root cause could be determined, there is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot due to the age of more than 10 years of the complained device a wear or use related root cause is the most likely reason of the complained malfunction.Per franchise complaint product investigation procedure (b)(4) is for complaints for which a non-manufacturing related probable cause has been identified no manufacturing record evaluation is required.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: CANNULATED CRUCIFORM SCREWDRIVER
• Common Device Name: SCREWDRIVERS.
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12339677
• Report Number: 8030965-2021-06820
• Device Sequence Number: 3001930
• Product Code: HXX
• UDI-Device Identifier: 07611819710894
• UDI-Public: (01)07611819710894
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 314.463
• Device Lot Number: 5106966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 09/29/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: CANNULATED CANCELLOUS SCREWS