MAUDE Adverse Event Report: SYNTHES GMBH VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L18 TAN; SCREW, FIXATION, BONE

Catalog Number	04.211.018TS
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
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: d2b: additional product code: hrs.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1: (b)(6) hospital.H3, h6: 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: it was reported that on (b)(6) 2023, the patient underwent a removal surgery.The primary surgery was performed with the clavicle plate and the screws for the clavicle diaphyseal fracture on (b)(6) 2022.When the plate was removed, the four screws broke under the screw heads.The surgeon turned the screw head twice to remove it and it broke under the screw head.Although the surgeon tried to remove the broken screws with hollow reamer and other instruments, they could not be removed.The four screw shafts remained in the body.The surgery was completed successfully within 30 minutes delay.Patient status/ outcome: progress is under observation.According to the surgeon, possible cause other than the product is too many screws and the screws were fixed too tightly.The surgeon asked the following questions.What is the number of cases of broken screws in relation to the number of va clavicle plates used in japan? which has more cases of broken screws, cortex screws or locking screws? how many cases of each? no further information is available.This report is for one (1) va lockscr ã¸2.7 he 2.4 self-tap l18 tan.This is report 3 of 4 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.H10 additional narrative: h6: device history record (dhr) review conducted: sterile part:04.211.018ts.Sterile lot no: 9l07988.Release to warehouse date: 11 feb, 2022.Expiry date: 01 feb, 2027.Manufacturing site: werk selzach.Supplier: früh verpackungstechnik ag.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile part: 04.211.018.Non-sterile lot: 624p946.Manufacturing site: werk selzach.Release to warehouse date: 27 jan, 2022.Supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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.G1.

• Brand Name: VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L18 TAN
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18240903
• Report Number: 8030965-2023-15122
• Device Sequence Number: 12552686
• Product Code: HWC
• UDI-Device Identifier: 10886982119018
• UDI-Public: (01)10886982119018
• 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: 2023
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.211.018TS
• Device Lot Number: 9L07988
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2022
• 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: 2.7 TI VA LCP CLAV PL SFT/ CS3/ LFT/ -S; 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 L20 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L20 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L20 TAN
• Patient Age: 25 YR
• Patient Sex: Male