MAUDE Adverse Event Report: SYNTHES GMBH VA-LCP OLECR PL 2.7/3.5 LE 2HO L90 TAN; PLATE, FIXATION, BONE

Catalog Number 04.107.302S

Device Problem Device-Device Incompatibility (2919)

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

Event Date 01/09/2024

Event Type  malfunction  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, the patient underwent the orif for the left olecranon fracture.During plate fixation, all inserted locking screws could not be fully tightened.The number of inserted screws is unknown.Although the surgeon assembled the screwdriver shaft, the torque limiter, and the handle for tightening screws, the screws could not be fully tightened.Therefore, the surgeon tightened the screws with the same feeling as when the surgeon always did.The surgery was completed successfully within 30 minutes delay.No further information is available.This report is for one (1) va-lcp olecr pl 2.7/3.5 le 2ho l90 tan.This is report 2 of 4 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.H10 additional narrative: e3: reporter is a j&j employee.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.D10: date of concomitant therapy is 1/09/2024.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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.

• Brand Name: VA-LCP OLECR PL 2.7/3.5 LE 2HO L90 TAN
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18580356
• MDR Text Key: 333822907
• Report Number: 8030965-2024-01341
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819504677
• UDI-Public: (01)07611819504677
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/24/2024

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: 04.107.302S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1