MAUDE Adverse Event Report: SYNTHES GMBH PERCUTANEOUS INSERTION HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.010.046
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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.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
It was reported that on (b)(6) 20201 that the protection sleeve could not be attached to the aiming arm because it could not be placed over the insertion handle.The surgery was completed successfully free hand which resulted in a surgical delay of fifteen (15) minutes.The patient outcome was good and as expected.This report is for one (1) percutaneous insertion handle.This is report 4 of 5 for (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.H10 additional narrative: d4: lot part # 03.010.046, lot # l337798, release to warehouse date: april 24, 2017, manufacturer: hagendorf, no ncr's were generated during production.Visual inspection: the insert-handle long f/expert fn (p/n: 03.010.046, lot #: l337798) was returned and received at us customer quality (cq).Upon visual inspection, no issues were observed with the returned device.Functional test: a functional test was not performed as the device was returned by itself.Can the complaint be replicated with the returned device? unable to perform dimensional inspection: specified dimensions: aiming arm slot inner diameter.Measured dimensions: slot inner diameter = conforming.Device used - gauge pins.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed percutaneous insertion handle.Complaint confirmed? no investigation conclusion the complaint condition was not confirmed for the insert-handle long f/expert fn (p/n: 03.010.046, lot #: l337798).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: PERCUTANEOUS INSERTION HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11784135
• Report Number: 8030965-2021-03623
• Device Sequence Number: 14323055
• Product Code: LXH
• UDI-Device Identifier: 07611819773554
• UDI-Public: 07611819773554
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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: 03.010.046
• Device Lot Number: L337798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INSERT-HANDLE F/EXPERT TN+FN; INSERT-HANDLE F/EXPERT TN+FN; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - GUIDES/SLEEVES/AIMING: SLEEVE; INSERT-HANDLE F/EXPERT TN+FN; INSERT-HANDLE F/EXPERT TN+FN; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - GUIDES/SLEEVES/AIMING: SLEEVE