MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM ANGLED AWL; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Catalog Number	03.617.993
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Event year is reported as 2021; however exact date of event is unknown.Additional product code : ove.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 as no product was 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 on an unknown that the patient underwent for a surgery.During the surgery, when using the awl for the screw hole in the patient, the surgeon pulled out the awl and the sharp tip of the awl was still in the screw hole.The surgeon used forceps to pull out the awl tip.There was no delay reported.The surgery was completed successfully.There were no adverse consequences to the patient.Concomitant medical products: unknown zero profile screw (part# unknown, lot# unknown, quantity 1).This complaint involves one (1) device.This report is for (1) 2.0mm angled awl this report is 1 of 1 (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: 03.617.993.Lot: 8003212.Manufacturing site: hagendorf.Release to warehouse date: august 29, 2012.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the complaint device awl ø2 angl was returned to customer quality (cq) west chester for investigation.During visual inspection, no issues were identified on the device.Document /specification review: based on the date of manufacture, the current and manufactured version of drawings.For the part were reviewed: awl 40° angled complete and tip.Dimensional inspection: measured dimension: diameter of the tip: conforming.Conclusion: the returned device had no defect that could have resulted in the complaint.Hence, the complaint was not confirmed.No definitive root cause can be determined based on the provided information.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 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: 2.0MM ANGLED AWL
• Common Device Name: APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11771823
• Report Number: 8030965-2021-03554
• Device Sequence Number: 17251764
• Product Code: KWQ
• UDI-Device Identifier: 07611819933330
• UDI-Public: 07611819933330
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K152239
• 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): 04/08/2021

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: 03.617.993
• Device Lot Number: 8003212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 10/04/2021
• 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: UNK - SCREWS: ZERO-P