MAUDE Adverse Event Report: SYNTHES GMBH 2.4/2.7MM VA-LCP FIRST MTP FUSION PL/MED/0 DEG/RIGHT; PLATE, FIXATION, BONE

Catalog Number	02.211.236
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on october 27, 2023, there was a removal of plate and screws due to non-union and the screwdriver was damaged.This report is for one (1) 2.4/2.7mm va-lcp first mtp fusion pl/med/0 deg/right this is report 1 of 7 for complaint (b)(4).This complaint is related (b)(4) which captures the screwdriver which was damaged during removal surgery.
Additional 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: d9: complainant part is not expected to be returned for manufacturer review/investigation.H6: photo investigation: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device images.Visual analysis of the photo revealed that 2.4/2.7 va 1st mtp fusn pl/med/0 deg/rt presents light scratches all over the surface.Additionally, the edge of some locking holes were found stripped, most likely caused during the implantation and explanation process.Nothing indicative of a device nonconformance was observed on the provided evidence.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for 2.4/2.7 va 1st mtp fusn pl/med/0 deg/rt.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.The device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.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: 2.4/2.7MM VA-LCP FIRST MTP FUSION PL/MED/0 DEG/RIGHT
• Common Device Name: 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 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 18145110
• Report Number: 8030965-2023-14444
• Device Sequence Number: 7503351
• Product Code: HRS
• UDI-Device Identifier: 10886982054227
• UDI-Public: (01)10886982054227
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K100776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 02.211.236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: 2.7 MM CORTEX; UNK - SCREWS: 2.7 MM CORTEX; UNK - SCREWS: 2.7 MM VA LOCKING; UNK - SCREWS: 2.7 MM VA LOCKING; UNK - SCREWS: 2.7 MM VA LOCKING; UNK - SCREWS: 2.7 MM VA LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male