MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM/3.5MM TI VA-LCP OLECRANON PL 2H/LT/90MM-STER; PLATE, FIXATION, BONE

Catalog Number 04.107.302S

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/31/2021

Event Type  malfunction  

Manufacturer Narrative

Additional device product code: hwc.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the open reduction internal fixation (orif) surgery for elbow fracture with the 2 holes plate.During the surgery, the curve of the plate did not match the curve of the elbow.The surgeon did not want to bend the plate, but because the curve doesn't fit well, the surgeon bent the plate and the plate broke at the starting point of the curve.The surgeon used other plate (4 holes) without bending and the surgery was completed successfully within thirty (30) minutes surgical delay.The patient outcome is reported as stable.No further information is available.This report is for one (1) 2.7mm/3.5mm ti va-lcp olecranon pl 2h/lt/90mm-ster.This is report 1 of 1 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6- visual analysis of the returned sample revealed that va-lcp olecr pl 2.7/3.5 le 2ho l90 tan the plate was broken, and no other issues were identified.The dimensional inspection was performed, and it is within the specification limit.The observed condition drill bit ø1.1 l56/39 f/core hole in the device was consistent with a random component failure.The breakage has occurred due to reverse bending according to the surgical technique certain precautions must be followed during reverse bending.The plate holes have been designed to accept some degree of deformation.When bending, be careful not to distort locking holes.Significant distortion of the locking holes will reduce locking effectiveness.Do not bend the periarticular section of the anatomical plate.Reverse bending, bending the plate at the same place multiple times, or using incorrect instrumentation for bending may weaken the plate and lead to premature plate failure (e.G., breakage).Do not bend the plate beyond what is required to match the anatomy.¿ do not bend the plate using the threaded drill guide.Damage may occur to the plate hole threads.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 broken condition of the va-lcp olecr pl 2.7/3.5 le 2ho l90 tan.While no definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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 #: 04.107.302s.Lot #: 148p592.Manufacturing site: selzach.Supplier: synthes usa hq, inc.Release to warehouse date: 13 may 2021.Expiration date: 01 may 2031.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: 2.7MM/3.5MM TI VA-LCP OLECRANON PL 2H/LT/90MM-STER
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12379044
• MDR Text Key: 268523070
• Report Number: 8030965-2021-07297
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819504677
• UDI-Public: (01)07611819504677
• Combination Product (y/n): N
• PMA/PMN Number: K120070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.107.302S
• Device Lot Number: 148P592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Date Manufacturer Received: 09/20/2021
• Patient Sequence Number: 1