MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM TI VA LCP CLAVICLE PLATE SHAFT/ CS3/ RIGHT/ STERILE; PLATE, FIXATION, BONE

Catalog Number	04.112.625S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
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 on (b)(6) 2023, the patient underwent an orif surgery for clavicle midshaft fracture with implants in question and 2 sutures.After surgery, on (b)(6) 2023, it was found that the lateral side of the plate appeared to be slightly raised.On (b)(6) 2023, it was confirmed that the 1 screw inserted into the lateral bone fragment was broken.On (b)(6) 2023, it was confirmed that a total of 4 screws inserted into the lateral bone fragment were broken.It is unknown which screws are inserted into which screw holes.No further information is available.This report is for one (1) 2.7mm ti va lcp clavicle plate shaft/ cs3/ right/ sterile.This is report 5 of 5 for complaint (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.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturing location: elmira / packaged, sterilized and released by: monument release to warehouse date: 24-jan-2022.Expiration date: 01-jan-2032.Part number: 04.112.625s, ti segmental shaft plate mid-shaft/right/large-sterile lot number: 601p880 (sterile) lot quantity: 48 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.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from the photo.Visual analysis of the photo revealed that the va-lcp clavic pl 2.7 shaft cs3 r tan had migrated out of the bone from the lateral aspect.X-ray images show a plate and screw construct at the right clavicle with signs of locking screw breakage and bone fracture.Four locking screws and one cortex screw are visible at the lateral aspect, all locking screws appear to have broken from the junction of the head and the shaft, this event could have contributed to the plate rising up and backing out of the surface of the bone.The remaining screws located at the medial aspect do not present any signs of defect.Per medical assessment, the injury image looks like a neer type 2, which is an inherently unstable fracture pattern.These displaced lateral-third clavicular fractures are prone to delayed union or nonunion (up to 40%), recurrent pain and instability caused by several factors including but not limited to significant fragment dislocation and/or a small lateral fragment available for screw purchase and fixation when orif is chosen as treatment.In some cases, the lateral fragment is small and is also of poor bone quality; which has led some authors to conclude that vertical stability cannot be sufficiently achieved with plate fixation alone.Therefore, it was not possible to determine a root cause for the overall reported issue.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 confirmed for the va-lcp clavic pl 2.7 shaft cs3 r tan.There is no indication that a design or manufacturing issue has caused the complaint condition.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.7MM TI VA LCP CLAVICLE PLATE SHAFT/ CS3/ RIGHT/ STERILE
• 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 ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 17246202
• Report Number: 8030965-2023-08240
• Device Sequence Number: 11979795
• Product Code: HRS
• UDI-Device Identifier: 07612334214492
• UDI-Public: (01)07612334214492
• 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: 2023
• 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: 04.112.625S
• Device Lot Number: 601P880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2022
• 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 L18 TAN; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L18 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L18 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L18 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L20 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L22 TAN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male