MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 60MM; SCREW, FIXATION, BONE

Model Number	04.211.060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
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.If the information is unknown, not available or does not apply.H10 additional narrative: d2b additional device product codes: hrs.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 an unknown date, after surgery, 3 screws for va-dhp were found to be broken.On (b)(6) 2023, the patient underwent an orif surgery for humerus supracondylar comminuted fracture and olecranon fracture.The preoperative plan was to use a double plate at the humerus, but judging from the condition of the fracture, a va-dhp and olecranon plate were used.The va-dhp was used only at the medial side of the humerus.After the surgery three screws were found broken.Since the patient had been in postoperative splint fixation and had been instructed to perform rehabilitation only distal to the wrist, there was no particular stress on the fracture site.Although it is possible that the patient may have been making turning movements, etc.While sleeping, the surgeon suspects the insufficient strength of the screws because the breakage occurred approximately 1 week after surgery.On (b)(6) 2023, a reoperation will be performed.In the reoperation, only the most distal screw will be left, and the remaining screws and plate will be removed, and k-wires will be used for the treatment.This report involves one (1) 2.7mm ti va lckng scr slf-tpng with t8 stardrive recess 60mm.This is report 2 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.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.Lot # 8l46261 manufacturing site: werk selzach release to warehouse date: 10 aug 2021 expiration date: 01 aug 2031 supplier: (b)(4) a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 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.H10 additional narrative: device returned.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 va lockscr ã¸2.7 head 2.4 self-tap l60 ta was broken across the neck between the head and the shaft, the head remains fixed on the plate.Both fragments were received in the evidence provided.No other issues were observed.A dimensional inspection for the va lockscr ã¸2.7 head 2.4 self-tap l60 ta was not 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 head 2.4 self-tap l60 ta 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.Device history review (dhr): part # 04.211.060s lot # 8l46261 manufacturing site: werk selzach release to warehouse date: 10 aug 2021 expiration date: 01 aug 2031 supplier: (b)(4) a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile part # 04.211.060 non-sterile lot # 256p189 manufacturing site: werk selzach release to warehouse date: 01 july 2021 supplier: (b)(4) 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: 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 60MM
• 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 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16833369
• Report Number: 8030965-2023-05417
• Device Sequence Number: 12557848
• Product Code: HWC
• UDI-Device Identifier: 10886982119223
• UDI-Public: 10886982119223
• 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: 2023
• Device Explanted 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,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: 04.211.060
• Device Catalogue Number: 04.211.060S
• Device Lot Number: 8L46261
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 05/22/2023; 07/07/2023; 08/22/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 06/06/2023; 07/10/2023; 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2021
• 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: UNK - PLATES: TRAUMA; UNK - SCREWS: LOCKING; VA LOCKSCR ø2.7 HEAD 2.4 SELF-TAP L18 TA; VA LOCKSCR ø2.7 HEAD 2.4 SELF-TAP L54 TA; VA LOCKSCR ø2.7 HEAD 2.4 SELF-TAP L54 TA; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L18 TA; VA-LCP DHP 2.7/3.5 MED R X-LONG 6HO L134
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown