MAUDE Adverse Event Report: SYNTHES GMBH LCP MED PROX-TIBPL 4.5 R SHAFT 6HO L142; PLATE, FIXATION, BONE

Catalog Number 239.986

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.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.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that during the procedure, the surgeon wanted to take off a screw because he thought that the plate was not at the right location and it was impossible to take it off.It is unknown if surgery was delayed due to the reported event, the procedure was successfully completed.This report is for one (1) lcp med prox-tibpl 4.5 r shaft 6ho l142.This report is 1 of 8 for (b)(4).

• Brand Name: LCP MED PROX-TIBPL 4.5 R SHAFT 6HO L142
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY
• Manufacturer Contact: kara dpaitty-bovard ; 1308 wrights lane east; west chester, PA
• MDR Report Key: 11690129
• MDR Text Key: 246438562
• Report Number: 8030965-2021-03029
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819916630
• UDI-Public: (01)07611819916630
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K050646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 239.986
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1