MAUDE Adverse Event Report: SYNTHES GMBH AWL

Catalog Number	359.213
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).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.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 during an unknown procedure, a brown substance leaked from the instruments that resulted in contamination of the hammer, inserter and awl.There was a surgical delay of (30) minutes.The procedure was successfully completed using replacement devices.It was stated that the patient required an open reduction internal fixation procedure due to the instruments not being available.This report is for (1) awl.This is report 3 of 3 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.H3, h4, h6: part number: 359.213, lot number: 2009257, manufacturing site: haegendorf, release to warehouse date: february 2, 2021.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the pfriem 30x 215mm (p/n: 359.213, lot #: 2009257) was returned and received at us customer quality (cq).Upon visual inspection on the returned device, it was found that the handle was discolored.Titanium elastic nail tray was not returned therefore the attached photographs were reviewed and confirmed the complaint condition as the image showed leakage from the device when sterilization.No other issues were identified with the returned device.The received condition is consistent with the complaint condition thus the complaint is confirmed.Device failure/defect identified? yes.Document/specification review the following drawing(s) was reviewed: pfriem 30x215mm: current and manufactured.Dimensional inspection: a dimensional inspection was not done as its not relevant to the complaint condition of foreign substance.Based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Investigation conclusion: the overall complaint was confirmed for the instrument as the presence of foreign substance on the tray.A definitive root cause for this complaint could not be determined.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.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.
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, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.H3, h4, h6: 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.

• Brand Name: AWL
• Common Device Name: AWL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11837856
• Report Number: 8030965-2021-03987
• Device Sequence Number: 4443682
• Product Code: HWJ
• UDI-Device Identifier: 07611819096622
• UDI-Public: (01)07611819096622
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: consumer,foreign,health profe
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 359.213
• Device Lot Number: 2009257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 06/10/2021; 07/01/2021; 07/08/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 07/01/2021; 07/02/2021; 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention