MAUDE Adverse Event Report: SYNTHES GMBH DRILL STOP FOR 03.037.022; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.037.023
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023 the surgeon implanted a trochanteric fixation nail-advanced (tfna) to treat patient's left intertrochanteric fracture.During procedure the surgeon had a difficult time getting the lateral opening drill and the 6/9mm step drill to pass through the nail.He proceeded to implant the tfna lag screw and also implant the distal interlocking screws.Surgeon did not notice on interoperative x rays that the lag screw was anterior to the nail.Upon review of the post operative x rays surgeon realized that the lag screw was implanted anterior to the nail and that it did not pass through the nail.It was determined that the nail was not assembled to the insertion handle correctly which allowed the angle guide to rotate and miss the nail anterior.Revision surgery was performed on july 13, 2023 where the nail and lag screw were removed without issue and a new nail and lag screw were implanted in the correct orientation.The status of the patient at this time is that they are recovering and the revision nail surgery was successful.There was no delay during the revision procedure.This report is for one (1) unknown drill bit this is report 1 of 5 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d1, d2, d3, d4, g4-510k: this report is for an unknown drill bit/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

• Brand Name: DRILL STOP FOR 03.037.022
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 17417113
• Report Number: 8030965-2023-09521
• Device Sequence Number: 12395856
• Product Code: LXH
• UDI-Device Identifier: 10886982070395
• UDI-Public: (01)10886982070395
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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: 03.037.023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11/130 DEG TI CANN TFNA 380/LEFT - SILE; TFNA FENESTRATED SCREW 120MM - STERILE; UNK - DRILL BITS: TRAUMA; UNK - NAIL INSERTION HANDLES; UNK - SCREWS: NAIL DISTAL LOCKING
• Patient Age: 69 YR
• Patient Sex: Unknown