MAUDE Adverse Event Report: MONUMENT DEPUY SYNTHES PRODUCTS INC 4.5MM BROAD LCP® PLATE 14 HOLES/260MM; PLATE, FIXATION, BONE

Model Number 226.641

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

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.Event date: unknown when the device broke.Complainant part is not expected to be returned for manufacturer review/investigation.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 history: part: 226.641; lot: l882231; release to warehouse date: 02 may 2018; manufacturing site: (b)(4); expiration date: n/a.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.

Event Description

Device report from synthes reports an event in brazil as follows: it was reported a plate was implanted on an (b)(6) 2022, but broke post-operatively on an unknown date.A revision surgery occurred on (b)(6) 2022 and a new plate implanted.The second plate also broke post-operatively.There was no surgical delay and no fragments were left behind in the patient.This complaint captures the rupture of the first plate implanted.This is report 1 of 1 for (b)(4).This report is for an lcp plate.

• Brand Name: 4.5MM BROAD LCP® PLATE 14 HOLES/260MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): MONUMENT DEPUY SYNTHES PRODUCTS INC; 1101 synthes avenue; monument CO 80132
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15668411
• MDR Text Key: 302364854
• Report Number: 1719045-2022-00026
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982159212
• UDI-Public: (01)10886982159212
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K082807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 226.641
• Device Catalogue Number: 226.641
• Device Lot Number: L882231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female