MAUDE Adverse Event Report: SYNTHES GMBH DRIVING CAP WITH HANDLE ADAPTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.010.047
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2021
Type of Reportable Event	Malfunction
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 insertion handle was found to be stuck in the driving cap with handle adapter.The two instruments could not be disassembled.The issue was found during loan kit inspection.There was no known patient involvement.There is no further information available.This report is for (1) driving cap with handle adapter.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Reporter is a j&j employee.The device was 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.
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- the complaint device (insert-handle f/etn radioluc short) was returned for investigation.After physical review of the part, it was possible to confirm the allegation.It is not possible to disassemble devices.Per surgical technique 097637-200428 it was confirmed product code 03.010.013 (insert-handle f/etn radioluc short) is not intended to complete mating operation with 03.010.047 (connec l141 f/insertion handle).No design issues were observed during the document/ specification review.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 : part: 03.010.047, lot: 7582802, manufacturing site: hagendorf, supplier: n/a, release to warehouse date: 23 september 2011, expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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: DRIVING CAP WITH HANDLE ADAPTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12820341
• Report Number: 8030965-2021-09541
• Device Sequence Number: 4958110
• Product Code: LXH
• UDI-Device Identifier: 07611819760844
• UDI-Public: (01)07611819760844
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2021

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: 03.010.047
• Device Lot Number: 7582802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2021
• Supplement Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INSERT-HANDLE F/ETN RADIOLUC SHORT
• Patient Sex: Unknown