MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM LCP PLATE 5 HOLES 72MM; PLATE,FIXATION,BONE

Catalog Number 223.551

Device Problem Device Slipped (1584)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Additional procode: hwc, ktt.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the photos provided.The picture displaying the x-ray was reviewed, and the complaint condition could be confirm since the x-ray showed the screw backing out from the plate.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the subject complaint is confirmed as the provided x-ray image showed one out of the five screws backing out from the plate.Moreover as the devices have not been returned to perform inspection of all as received impacted devices, this complaint will be confirm for the plate.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the picture) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Device history lot part/lot combination are unknown at synthes (b)(4), no dhr review possible.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 on an unknown date, one of the screws loosened in the 3.5mm lcp plate a few days after being implanted.There is no further information available.This report is for one (1) 3.5mm lcp plate 5 holes 72mm.This is report 1 of 2 for (b)(4).

• Brand Name: 3.5MM LCP PLATE 5 HOLES 72MM
• 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 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11639341
• MDR Text Key: 249425007
• Report Number: 8030965-2021-02739
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819241053
• UDI-Public: (01)07611819241053
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K082807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 223.551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2021
• 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
• Patient Outcome(s): Required Intervention