MAUDE Adverse Event Report: SYNTHES GMBH INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM; SCREWDRIVERS

Catalog Number	03.010.472
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: reporter is a j&j employee.The device was received, the investigation is in progress, 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 the interlock screwdriver was flagged as broken prior to surgical use.The screwdriver had not been reassembled prior to sterilization.Before the case, the scrub nurse reassembled the screwdriver.They noticed the tip was deformed and the instrument was unusable.It is unknown when the damage occurred.There is no further information available.This report is for one (1) inter-lock screwdriver t25/3.5mm hex/330mm.This is report 1 of 1 for (b)(4).

• Brand Name: INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10863036
• Report Number: 8030965-2020-09033
• Device Sequence Number: 16794512
• Product Code: HXX
• UDI-Device Identifier: 07611819464032
• UDI-Public: (01)07611819464032
• 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): 10/22/2020

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: 03.010.472
• Device Lot Number: L799385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1