MAUDE Adverse Event Report: SYNTHES GMBH LCP OLECRANPL 3.5 R 4HO L111; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	436.504
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device available for evaluation (2021 reports): device returned.Occupation: initial reporter is j&j company representative investigation summary: background: it was reported that at the opening, the plate was cut on a part.This complaint involves one (1) device.Investigation flow: damage visual inspection: the lcp olecranpl 3.5 r 4ho l111 (p/n: 436.504, lot #: 1l23677) was returned and received at us cq.Upon visual inspection, it was observed that the plate was broken at the distal end and the broken fragments were not returned.No other issues were identified.The reported condition of upon receipt could not be confirmed as no relevant images/evidence was provided.Device failure/defect was identified.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review: the following documents were reviewed: lcp-olecranon platte 3.5 re: se_055624, rev e (current and manufactured).No design issues or discrepancies were identified.Complaint was confirmed, the device received was broken.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed as the distal end of the plate was broken.No definitive root cause could be determined based on the provided information.The unintended forces might have contributed to the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.Device history lot , part:436.504, lot: 1l23677, manufacturing site: (b)(4), supplier: (b)(4), release to warehouse date: 16.Sep.2018.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.
Event or Problem Description
Device report from synthes europe reports an event in (b)(6) as follow: it was reported that at the opening, the plate was cut on a part.This report is for one (1) 3.5mm ti lcp olecranon plate 4 holes/right/112mm.This report is 1 of 1 for (b)(4).

• Brand Name: LCP OLECRANPL 3.5 R 4HO L111
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12028329
• Report Number: 8030965-2021-05096
• Device Sequence Number: 11106326
• Product Code: KTT
• UDI-Device Identifier: 10886982217936
• UDI-Public: (01)10886982217936
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 436.504
• Device Catalogue Number: 436.504
• Device Lot Number: 1L23677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1