MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH LCP METAPHYSPL 3.5 9HO L125 TI; APPLIANCES,FIXATION,NAIL/BLD/ PL COMBO,MULTI COMP, METAL COM

Catalog Number 423.409S

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unk - plate: trauma/unknown lot.Part and lot numbers are unknown; udi number is unknown.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 as no product was received.The investigation could not be completed, no product was received; 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent osteosynthesis surgery for right proximal ulna fracture with the metaphyseal plate.During the rehabilitation, the patient reported pain, and on (b)(6), the surgeon confirmed by x-rays that the plate had been broken.On (b)(6), the patient underwent re-operation by replacing the plate with a proximal ulna plate.The bone doesn¿t unite, and the patient rehabilitates now.The additional incision (3cm) was needed.The concentration of the force due to the lack of fixation was the cause of the breakage of the plate.Concomitant device/s reported: unknown screws (part# unknown, lot# unknown, quantity# unknown).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 was 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.

Event Description

Updated event description it was reported that on (b)(6) 2019, the patient underwent osteosynthesis surgery for right proximal ulna fracture with the metaphyseal plate in question.During the rehabilitation, the patient reported pain, and on (b)(6) the surgeon confirmed by x-rays that the plate had been broken.On (b)(6) the patient underwent reoperation by replacing the plate with a proximal ulna plate.The bone doesn¿t unite, and the patient rehabilitates now.The additional incision (3cm) was needed.The surgeon commented that the concentration of the force due to the lack of fixation was the cause of the breakage of the plate.No further information is available.Concomitant device/s reported: cortex screw (part# 404.816s, lot# 2l02565, quantity# 1), cortex screw (part# 404.816s, lot# 2l45899, quantity# 1), cortex screw (part# 404.816s, lot# 4l60600, quantity# 1), cortex screw (part# 404.818s, lot# 4l52469, quantity# 1), cortex screw (part# 404.820s, lot# 4l64059, quantity# 1), cortex screw (part# 404.826s, lot# 3l06351, quantity# 1), locking screw (part# 412.104s, lot# 5l21198, quantity# 1), locking screw (part# 412.110s, lot# l854443, quantity# 1).

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.Investigation site: cq zuchwil selected flow: damaged.Visual inspection: the plate is broken apart at the crossover between hole 5 and 6 counted from the end side.Furthermore, there are several mechanical damages visible on the surface.The anodized layer is partially worn away at the damaged areas, which is an indication of post-manufacturing usage.All features related to the reported complaint condition were reviewed and no other issues were identified.Drawing/specification review: the manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Furthermore, as indicated in the manufacturing documents, the correct material was used according iso 5832-2 summary the complaint is confirmed as the plate is broken apart as complained.The for the complaint relevant dimensions were checked as far as possible and found to be within specifications.This lot of 12 pieces was manufactured in october 2018, all devices are distributed and we are not aware of any other complaint for this part- and lot number combination.This and the findings above let us exclude a manufacturing related issue.Based on the provided information we are not able to determine the exact cause of this breakage.We can only assume that any occurrence during the healing process, e.G.Non-union, delayed union, mal-union, overloading of the osteosynthesis or a combination of different factors, did lead to a fatigue failure.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.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 as no product related issue could be detected device history lot part: 423.409s, lot: 1l95976, manufacturing site: grenchen, release to warehouse date: oct.30 2018, expiry date: oct.01, 2028.A manufacturing record evaluation was performed for the finished device lot number, 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.

• Brand Name: LCP METAPHYSPL 3.5 9HO L125 TI
• Type of Device: APPLIANCES,FIXATION,NAIL/BLD/ PL COMBO,MULTI COMP, METAL COM
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9577310
• MDR Text Key: 174622876
• Report Number: 8030965-2020-00252
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• PMA/PMN Number: K033805
• 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: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 423.409S
• Device Lot Number: 1L95976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Date Manufacturer Received: 03/02/2020
• Patient Sequence Number: 1
• Treatment: CORTSCR Ø3.5 SELF-TAP L16 TI; CORTSCR Ø3.5 SELF-TAP L16 TI; CORTSCR Ø3.5 SELF-TAP L16 TI; CORTSCR Ø3.5 SELF-TAP L18 TI; CORTSCR Ø3.5 SELF-TAP L20 TI; CORTSCR Ø3.5 SELF-TAP L26 TI; LOCKSCR Ø3.5 SELF-TAP L16 TAN; LOCKSCR Ø3.5 SELF-TAP L28 TAN; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR