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	05/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in australia as follows: it was reported that awl tip (03.617.993) broke off during procedure.Whilst using the zero p angled awl to create a pathway for the screw, the tip of the awl broke off.The broken fragment was retrieved from the patient and procedure was completed with no delay.This complaint involves one (1) device awl ø2 angl.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (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.Additional product code: kwq.Complainant part is not expected to be returned for manufacturer review/investigation.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.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d4, e1, h3, h4, h6: part: 03.617.993.Lot: 8403662.Manufacturing site: werk hagendorf.Release to warehouse date: 27 june 2013.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the device from the received images.Visual analysis of the photo revealed that the tip of the awl ø2 angl was broken.No other product problems were identified.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the tip of the awl ø2 angl, p/n: 03.617.993, broke off.The broken fragment was not returned for examination.No other problems identified.A dimensional inspection was unable to be performed due to device design.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces as mentioned in the event description.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the awl ø2 angl, p/n: 03.617.993 would contribute to the complained device issue.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.Drawing/specifications reviewed current and manufactured revisions were reviewed.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.D1, d2, d9, e3.

• 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
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14804343
• Report Number: 8030965-2022-04331
• Device Sequence Number: 14638507
• Product Code: KWQ
• UDI-Device Identifier: 07611819933330
• UDI-Public: (01)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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022
• 2 Devices were Involved in the Event: 1 2

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: 8403662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2013
• 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
• Patient Sex: Unknown