MAUDE Adverse Event Report: SYNTHES GMBH THREADED LCP(TM) DRILL GUIDE F/LCP(TM) DISTAL RADIUS PLATES; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	323.029
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2024, the patient underwent an unknown surgery treating the distal radius.It was confirmed that the patient had had bilateral fractures of the distal ends of the radius, and tcp products had been used bilaterally.A postoperative x-ray of the right side showed that the contralateral cortical bone was cracked where the cortex screw was inserted.The rotating part at the base of the handle did not move well, making it difficult to insert screws.It was difficult to attach the drill sleeve in question to locking holes and stability could not be obtained.When the drill sleeve was tightened strongly to stabilize it, it became difficult to remove from a plate.For the drill sleeve, it was difficult to attach to locking holes and stability could not be obtained.When it was tightened strongly to stabilize it, it became difficult to remove from a plate.The surgery was completed successfully with no surgical delay.Patient was listed as stable pc ((b)(6)) captures the left radius.Pc ((b)(6)) captures the right radius.Pc ((b)(6)) to capture the postoperative event on the right side.This report is for threaded lcp(tm) drill guide f/lcp(tm) distal radius plates 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: initial reporter is j&j company representative 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.
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.H10 additional narrative: g1 h4 device history part# 323.029 lot # 3726747 manufacturing site: werk hägendorf supplier: na release to warehouse date: 18 mar 2011 expiration date: na a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified 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: THREADED LCP(TM) DRILL GUIDE F/LCP(TM) DISTAL RADIUS PLATES
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF; im bifang 6; hägendorf CO 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18869212
• Report Number: 8030965-2024-03427
• Device Sequence Number: 15400309
• Product Code: FZX
• UDI-Device Identifier: 07611819274105
• UDI-Public: 07611819274105
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 323.029
• Device Lot Number: 3726747
• 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: 02/21/2024
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2011
• 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: HANDLE W/QUICK-COUPL L110; UNK - PLATES: TRAUMA; UNK - SCREWS: TRAUMA
• Patient Sex: Unknown