MAUDE Adverse Event Report: SYNTHES GMBH 3.0MM BIHEXAGONAL SCREWDRIVER WITH T-HANDLE

Catalog Number	03.607.001
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: reporter is a synthes employee.: part: 03.607.001 lot: 7591730 manufacturing site: (b)(4).Release to warehouse date: september 12, 2011 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the screwdriver bihex ø3 w/t-handle was received at us customer quality (cq).Upon visual inspection, the distal tip of the device has broken off.The broken fragment was not returned.Dimensional inspection: measured dimensions: distal shaft od = conform middle shaft od = conform document/specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the distal tip of the complaint device has broken off.Although no definitive root-cause can be determined, it is likely the device encountered unintended forces greater than what the device was validated to withhold.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 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 (b)(6) reports an event as follows: it was reported that prior to a procedure on (b)(6), 2021, it was discovered that a device in the loan set was damaged and had been delivered as such.Another instrument was used for the procedure.This report is for a 3.0mm bihexagonal screwdriver with t-handle.This is report 1 of 1 for (b)(4).

• Brand Name: 3.0MM BIHEXAGONAL SCREWDRIVER WITH T-HANDLE
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11787279
• Report Number: 8030965-2021-03664
• Device Sequence Number: 3634410
• Product Code: HXX
• UDI-Device Identifier: 07611819185371
• UDI-Public: (01)07611819185371
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Report Date (Section B): 02/11/2021

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: 03.607.001
• Device Lot Number: 7591730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1