MAUDE Adverse Event Report: SYNTHES GMBH VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L22 TAN; SCREW, FIXATION, BONE

Model Number	04.211.022
Medical Device Problem Codes	Break (1069); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/01/2022
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 on (b)(6) 2022, the patient underwent open reduction/internal fixation for a fracture of the proximal end of the clavicle with the products in question.The surgery was competed successfully.Later, on an unknown date, the screws were coming out, so these screws were removed on (b)(6) 2022.Two screws were extracted.One had loosening and the other was broken off under the head.The surgeon was concerned that the screws had come loose not long after the plate insertion.The surgery was completed successfully without any delay.The patient was reported to be stable.No further information is available.This report involves one unk - screws: trauma.This is report 1 of 2 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.Date of event: only the event month and year is known.This report is for an unknown screws: trauma/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.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.
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.D2b: additional device product code: hrs.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
This report is for one (1) va lockscr ã¸2.7 he 2.4 self-tap l22 tan.
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: 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 va lockscr ã¸2.7 he 2.4 self-tap l22 tan, p/n: 04.211.022ts, broke off.The broken fragment was not returned for evaluation.The allegation of migration/backout/pull-out/subsidence, was not confirmed as no patient radiographs were provided to assess the condition.A dimensional inspection was unable to be performed due to post-manufacturing damage.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 l22 tan, p/n: 04.211.022ts would not 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? yes, reviewed.Dimensional inspection: n/a.Device history lot given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.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 L22 TAN
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15997207
• Report Number: 8030965-2022-11221
• Device Sequence Number: 12204327
• Product Code: HWC
• UDI-Device Identifier: 10886982119032
• UDI-Public: (01)10886982119032
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100776
• 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: Other Health Care Professional
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.211.022
• Device Catalogue Number: 04.211.022TS
• 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: 11/29/2022
• Supplement Date Received by Manufacturer: 12/19/2022; 01/12/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 12/20/2022; 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: TRAUMA; VA-LCP CLAVIC PL 2.7 MED R TAN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown