MAUDE Adverse Event Report: SYNTHES GMBH HANDLE FOR 90° SCREWDRIVER; DRILL, BONE, POWERED

Catalog Number	03.505.004
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional product code: dzj hxx.Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.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, patient underwent for a surgical procedure.During the surgery, when piercing piece assembled to air peng does not connect.The surgery was completed without delay.The patient outcome is unknown.This complaint involves two(2) devices.This report is for (1) handle for 90° screwdriver.This is report 2 of 2 or complaint (b)(4).
Additional 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.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the video.The video was reviewed and the complaint condition is confirmed.The hand piece and shaft of the screwdriver appears to be assembled correctly in the video provided.The screwdriver appears to be jammed/seized as it does not spin when connected to air.A definitive assignable root cause could not be determined based on the provided information.No valid lot number was provided or found in the photos, therefore no dhr review was completed.The dhr review will be revisited if a valid lot number is provided or the physical device is received.As the device was not returned, an as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.During the investigation, no product design issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.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.
Additional 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.H3, h4, h6: part 03.505.004, lot 8186238: manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: august 16, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a product investigation was completed: visual analysis of the returned sample revealed that there was no damage or defects with the device.A dimensional inspection was performed and met specifications.The drawings reflecting the current and manufactured revisions were reviewed.A functional test was performed, the shaft and handle were assembled and locked together without issues.Manual device was used to simulate the pen drive movement, and the gear rotation was done successfully with no signs of failure.The complaint condition was not able to be replicated.However, since the device can be seen not to function as intended in the provided video, the reported condition is being confirmed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the device would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 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: HANDLE FOR 90° SCREWDRIVER
• Common Device Name: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12969183
• Report Number: 8030965-2021-10099
• Device Sequence Number: 4451937
• Product Code: DZI
• UDI-Device Identifier: 07611819187481
• UDI-Public: (01)07611819187481
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K082649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2021

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: 03.505.004
• Device Lot Number: 8196238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 12/16/2021; 02/18/2022
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 12/17/2021; 03/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SHAFT
• Patient Sex: Male