MAUDE Adverse Event Report: SYNTHES GMBH VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L16 TAN; SCREW, FIXATION, BONE

Model Number	04.211.016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
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.Procode: hrs.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Initial reporter postal code: (b)(6).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 or Problem Description
Device report from synthes reports an event in japan as follows: this pc is related to (b)(4) which reports the screw breakage.This pc reports the pain.It was reported that on unknown date, the patient had an injury to the clavicle, and after conservative treatment, pseudoarthrosis developed.On (b)(6) 2022, the patient underwent the clavicle fracture pseudoarthroplasty with the products in question because she was concerned about the protrusion of her collarbone.During an outpatient visit on (b)(6) 2022, the patient was observed to have 5 distal screw fractures.Since there were no complaints of pain at this point, the patient was decided to be followed up.In late (b)(6) 2022, the patient complains of pain and the implants were determined to be removed.On (b)(6) 2022, the implants were removed.It was observed that five distal screws broken off at the base of the head.The screw shaft portion appeared to protrude outside the bone on the x-ray, but after the plate was removed, the screw shaft portion could not be seen due to scarring.The surgeon used a halo reamer to cut the bone in the front and then used radio pliers and screw grasping forceps to safely remove the implants.It is confirmed by x-ray by the surgeon that there are no remaining fragments or other damage inside the body.The surgery was completed successfully without any surgical delay.Regarding the cause of the breakage, the surgeon commented that the implant must have been subjected to a considerable bounce load after plate fixation because the bone fragments were originally displaced significantly in the post-conservative treatment pseudoarticulation.Reoperation was due to extraction as described above.The surgeon was considering adding a fiber wire or k-wire because the x-ray did not show complete fusion, but the fracture was stable even after light loading on the fracture after plate removal (probably due to scarring), and the surgery was completed without additional treatment.It is preferred to investigate as much as possible by observing the actual broken part in cross section (is it metal fatigue? is the breakage caused by instantaneous impossibility?).The surgeon also commented that similar events would likely have occurred even without this plate, as other companies often use nearly equivalent screw diameters.This report is for one (1)va lockscr ã¸2.7 he 2.4 self-tap l16 tan.This is report 2 of 12 for complaint.
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, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for this 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.Sterile part: 04.211.016ts sterile lot no :8l79760, release to warehouse date: 16 nov 2021, expiry date: 01 nov 2026, manufacturing site: werk selzach.Supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the head of the va lockscr ã¸2.7 he 2.4 self-tap l16 tan was broken from the shaft, both fragments were returned.Additionally, the threads of the screw are heavily stripped, most likely caused during removal process of the fragment.A dimensional inspection for the va lockscr ã¸2.7 he 2.4 self-tap l16 tan was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the va lockscr ã¸2.7 he 2.4 self-tap l16 tan would contribute to the complained device issue.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.Drawing/specifications reviewed: the following source controlled drawings reflecting the current and manufactured revisions were reviewed: -2.7mm variable angle locking screw self-tapping, stardrive recess (current and manufactured).Dimensional inspection: n/a.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 LOCKSCR ø2.7 HE 2.4 SELF-TAP L16 TAN
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15814978
• Report Number: 8030965-2022-09932
• Device Sequence Number: 7043504
• Product Code: HWC
• UDI-Device Identifier: 10886982119001
• UDI-Public: (01)10886982119001
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103243
• 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,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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.211.016
• Device Catalogue Number: 04.211.016TS
• Device Lot Number: 8L79760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2022
• Supplement Date Received by Manufacturer: 01/05/2023; 03/14/2023
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 01/24/2023; 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2021
• 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 L14 TAN; CORTSCR Ø2.7 SELF-TAP L14 TAN; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L18 TA; VA-LCP CLAVIC PL 2.7 LAT CS2 LE TAN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female