MAUDE Adverse Event Report: SYNTHES GMBH IMPACTOR F/PFNA BLADE; EXTRACTOR

Catalog Number 03.010.410

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.Investigation summary: complaint is confirmed as we are able to confirm complaint description, the part fell apart most likely as the welding is broken, based on the received pictures.Product was not returned therefore no further investigation possible.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 (information or/and material), the investigation will be updated as applicable.Device history lot: part: 03.010.410, lot: 9464849, manufacturing site: (b)(4), release to warehouse date: jun 30, 2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, three (3) impactors were found to be unable to attach.It was noticed that the glue dissolved.The issue was noticed during the cleaning procedure.There was no patient or surgical involvement.This report is for one (1) impactor f/pfna blade.This is report 3 of 3 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.Investigation summary : complaint is confirmed as we are able to confirm complaint description, the part fell apart most likely as the welding is broken, based on the received pictures.Product was not returned therefore no further investigation possible.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 (information or/and material), the investigation will be updated as applicable.Visual inspection: the impactor f/pfna blade (part #:03.010.410, lot #: 9464849) was received at us cq.Upon visual inspection, the blue handle was unattached from the impactor blade.A brown substance comparable to a melted glue was observed in the area where the handle is assembled with the impactor blade.Device failure/defect identified? yes.Dimensional inspection: no dimension inspection was performed as there was no damage that warranted a dimensional inspection.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the device was received with its blue handle and impactor blade unattached.The impactor blade and the blue handle could be assembled back together but they won't stay connected firmly; thus the complaint is confirmed.No definitive root cause could be determined based on the provided information but it is likely that the defect is due to the component failure.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive 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: 03.010.410, lot: 9464849, manufacturing site: bettlach, release to warehouse date: jun 30, 2015.A manufacturing record evaluation was performed for the finished device lot number, 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.

Manufacturer Narrative

Product complaint # pc-(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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h11/b4:correction: alert date: 11/24/2020 provided for reporting.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.B4.

• Brand Name: IMPACTOR F/PFNA BLADE
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11186219
• MDR Text Key: 227980963
• Report Number: 8030965-2021-00371
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 07611819349476
• UDI-Public: (01)07611819349476
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2020

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: 03.010.410
• Device Lot Number: 9464849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/18/2021
• Supplement Dates Manufacturer Received: 01/19/2021; 03/03/2021
• Supplement Dates FDA Received: 02/04/2021; 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1