MAUDE Adverse Event Report: SYNTHES GMBH LCP HOOK PL 3.5 3HO L62 SST; PLATE, FIXATION, BONE

Catalog Number 02.113.103

Device Problem Migration (4003)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

It was reported on an unknown date that the summary of retrospective data for patients treated with depuy synthes lcp hook plate 3.5.This report is for one (1) lcp hook pl 3.5 3ho l62 sst.This is report 1 of 4 for complaint (b)(4).

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: device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation: reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.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: LCP HOOK PL 3.5 3HO L62 SST
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15565631
• MDR Text Key: 301475678
• Report Number: 8030965-2022-07970
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819333819
• UDI-Public: (01)07611819333819
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.113.103
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LCP HOOK PL 3.5 3HO L62 TI; LCP HOOK PL 3.5 3HO L62 TI; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention