MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM BROAD LCP® PLATE 12 HOLES/224MM; PLATE, FIXATION, BONE

Model Number 226.621

Device Problem Break (1069)

Patient Problem Non-union Bone Fracture (2369)

Event Date 01/01/2022

Event Type  Injury  

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.Date of event: only the event year is known.Additional product codes: hwc, ktt.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.

Event Description

It was reported that on an unknown date, the patient experienced a broken large fragment plate with twelve screws.The surgeon performed revision surgery on (b)(6) 2022 wherein the broken plate and 10 screws were removed.This report involves one 4.5mm broad lcp® plate 12 holes/224mm.This is report 1 of 1 for (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.H3, h6: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.

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.H3, h6: a product investigation was conducted.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the 4.5mm broad lcp plate 12 holes/224mm, was broken in two pieces, the two pieces were returned.No others problems were found.A dimensional inspection was unable to be performed for the 4.5mm broad lcp plate 12 holes/224mm, due to post manufacturing damage.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the 4.5mm broad lcp plate 12 holes/224mm would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H3, h6: a device history record (dhr) review was conducted: part # 226.621 synthes lot # 4719343 supplier lot # n/a release to warehouse date: 03 mar 2004 manufactured by: synthes monument no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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: 4.5MM BROAD LCP® PLATE 12 HOLES/224MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15529749
• MDR Text Key: 301040777
• Report Number: 8030965-2022-07721
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982159151
• UDI-Public: 10886982159151
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 226.621
• Device Catalogue Number: 226.621
• Device Lot Number: 4719343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/03/2022
• Supplement Dates Manufacturer Received: 10/11/2022; 11/04/2022
• Supplement Dates FDA Received: 11/01/2022; 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2004
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: LOCKING; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 137 KG