MAUDE Adverse Event Report: SYNTHES GMBH NEUTRAL DRILL GUIDE FOR 4.5MM CORTEX SCREW

Catalog Number	03.120.017
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j representative.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 that on an unknown date the drill guide was found fair wear and tear condition.It was unknown when and how it occurred.It was unknown if there was any procedure and patient involvement.This complaint involves one (1) device.This report is for (1) neutral drill guide for 4.5mm cortex screw.This report is 1 of 1 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 # 03.120.017, lot # 7563284, manufacturing site: werk hagendorf, release to warehouse date: 27 sep2011.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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: NEUTRAL DRILL GUIDE FOR 4.5MM CORTEX SCREW
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12512890
• Report Number: 8030965-2021-07925
• Device Sequence Number: 1101464
• Product Code: FZX
• UDI-Device Identifier: 07611819970151
• UDI-Public: 07611819970151
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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: 03.120.017
• Device Lot Number: 7563284
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 10/19/2021
• Patient Sequence Number: 1