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

Catalog Number 02.107.302

Device Problem Device-Device Incompatibility (2919)

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

Event Date 12/13/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.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, during implantation of a left olecranon with 2 holes plate, the surgeon proceeded to place the screws that go to the olecranon head which locks in variable angle of 4 screws, but only 1 is locked.Surgeon verified surgical technique several times; however this failure continues to persist.It was observed that when the screw was placed, it jumped whenever it came into contact with the plate and did not lock to it.The screw heads were damaged.Thus the 4-hole plate was used and the screws were locked with no further issues.The procedure was delayed for a few minutes.There was no patient impact.This report is for one (1) 2.7mm/3.5mm va-lcp olecranon pl 2h/lt/90mm.This is report 1 of 4 for complaint (b)(4).

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.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, during implantation of a left olecranon with 2 holes plate, the surgeon proceeded to place the screws that go to the olecranon head which locks in variable angle of 4 screws, but only 1 is locked.Surgeon verified surgical technique several times; however this failure continues to persist.It was observed that when the screw was placed, it jumped whenever it came into contact with the plate and did not lock to it.The screw heads were damaged.Thus the 4-hole plate was used and the screws were locked with no further issues.The procedure was delayed for a few minutes.There was no patient impact.This report is for one (1) 2.7mm/3.5mm va-lcp olecranon pl 2h/lt/90mm.This is report 1 of 4 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.H3, h4, h6: part 02.107.302, lot 62p2344: part manufacture date: july 21, 2020.Manufacturing location: elmira.This lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.H3, h6: a photo investigation was completed: a photo investigation was performed based on the provided photo.The image was reviewed, and the complaint condition is not confirmed.After the review of the photo provided, it was not found any defect on the alleged device.Photo provided has not enough quality and does not provide enough information to detect and confirm reported event.A definite assignable root cause could not be determined based on the provided information.As the device was not returned, and as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.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.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 VA-LCP OLECRANON PL 2H/LT/90MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13213514
• MDR Text Key: 286334654
• Report Number: 8030965-2022-00217
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819504462
• UDI-Public: (01)07611819504462
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K120070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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
• Device Operator: Health Professional
• Device Catalogue Number: 02.107.302
• Device Lot Number: 62P2344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 01/10/2022
• Supplement Dates Manufacturer Received: 02/08/2022
• Supplement Dates FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: LOCKING (QTY 3)