MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM TI VA LCP CLAVICLE PLATE SHAFT/ CS1/ LEFT/ STERILE; PLATE, FIXATION, BONE

Catalog Number	04.112.620S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in japan as follows: it was reported that the patient underwent open reduction/internal fixation surgery on (b)(6) 2022 for a clavicle trunk fracture with the products in question.The surgery was completed successfully without any delay.On (b)(6) 2022, the agency contacted and visited the surgeon and found that the proximal fixation had failed.3dct and x-rays confirmed that two screws (one cortical and one locking) in the proximal bone fragment had bounced upward with the plate and were out of the bone, while the remaining two locking screws remained in the bone with the screw heads penetrating the screw.The position of the implant appeared to the surgeon to be generally fine.The implant had failed when the patient slept with the affected side down and woke up in the morning.Extraction would be performed on (b)(6) 2022 and the fracture would be refixed with a competitor plate.This report involves one 2.7mm ti va lcp clavicle plate shaft/ cs1/ left/ sterile.This is report 1 of 3 for (b)(4).
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.Date of event: only the event year is known.Complainant part is not expected to be returned for manufacturer review/investigation.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.
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.H3, h4, h6: product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot manufacturing location: elmira / packaged, sterilized and released by: monument, release to warehouse date: 31-mar-2022, expiration date: 01-mar-2032, part number: 04.112.620s, ti segmental shaft plate mid-shaft/ left/small-sterile, lot number: 721p895 (sterile), lot quantity: (b)(4).Note: plate was manufactured by elmira; lot number 699p017.Parts were packaged, sterilized and released by monument.Production order traveler met all inspection acceptance criteria.Packaging label log was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Device history review this lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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
The patient outcome was reported to be stable.

• Brand Name: 2.7MM TI VA LCP CLAVICLE PLATE SHAFT/ CS1/ LEFT/ STERILE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES MONUMENT; 1101 synthes ave; monument CO 80132 7117
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15893344
• Report Number: 8030965-2022-10396
• Device Sequence Number: 6793670
• Product Code: HRS
• UDI-Device Identifier: 07612334214348
• UDI-Public: 07612334214348
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.112.620S
• Device Lot Number: 721P895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2022
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• 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: CORTSCR ø2.7 SELF-TAP L16 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L14 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L14 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L16 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L16 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L16 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L16 TAN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male