MAUDE Adverse Event Report: SYNTHES GMBH 2.7 VA LCKNG ANT PATELLA PL TI/3-HOLE/STERILE; PLATE, FIXATION, BONE

Catalog Number 04.137.004S

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Part number: (b)(4).Lot number: 74p1325 manufacturing site: raron release to warehouse: (b)(6) 2020 expiry date: 01.Oct.2030.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.The implant(s) was not returned and instead the investigation will be done based on the supplied image(s) from the attachments (1 picture and 3 x-ray image(s)).The image(s) and x-rays were reviewed, and the complaint condition could be not confirmed as the x-rays do not show anything broken and it is very difficult to tell from the picture if the device is broken.As the implant(s) was not returned an as received condition, dimensional inspection, material or drawing reviews are not applicable.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 images) 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 preventative action is proposed.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 (b)(6) reports an event as follows: it was reported on an unknown date when inserting the variable angle (va) locking screw 2.7 into the va locking patella plate 2.7 anterior 3-hole (04.137.004s / 74p1325) in the left and right leg hole, the legs were broken.The connection/the bridge was broken when locking the screw with the torque limiter.The leg was not reverse bent, there was just a slight contouring of the legs towards the patella as necessary.Also, the middle leg was bent but did not break.The plate was not replaced and the lcp 2.7 screw (blue) in fixed angle with this patella plate was not used.Concomitant device reported: unk - screws: locking: (part# unknown; lot# unknown; quantity: unknown).Unk - torque devices: (part# unknown; lot# unknown; quantity: unknown).Unk insertion instrument (part# unknown; lot# unknown; quantity: unknown).Unk - bending instruments: trauma (part# unknown; lot# unknown; quantity: unknown).This report is for one (1) 2.7 va lckng ant patella pl ti/3-hole/sterile.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.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: 2.7 VA LCKNG ANT PATELLA PL TI/3-HOLE/STERILE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11776796
• MDR Text Key: 249055297
• Report Number: 8030965-2021-03574
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K201578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.137.004S
• Device Lot Number: 74P1325
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2021
• Patient Sequence Number: 1
• Treatment: UNK - BENDING INSTRUMENTS; UNK - INSERTION INSTRUMENTS: TRAUMA; UNK - SCREWS: LOCKING; UNK - TORQUE DEVICES; UNK - BENDING INSTRUMENTS; UNK - INSERTION INSTRUMENTS: TRAUMA; UNK - SCREWS: LOCKING; UNK - TORQUE DEVICES
• Patient Outcome(s): Required Intervention