MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM; SCREW, FIXATION, BONE

Model Number	202.878
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in australia as follows: it was reported that during an open reduction internal fixation (orif) procedure for the clavicle, the cortex screw head sheared off on tightening in the most medial hole of the lateral clavicle plate.The screw head was retrieved and the screw shaft was retained in the clavicle.The plate is planned to be removed in three to nine (3 ¿ 9) months and the screw shaft will be removed along with it.No surgical delay was encountered as the screw was left as is and the other holes of the plate were filled.This report is for a cortex screw.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Common device name: additional product code: hrs.Device evaluated by mfr and device manufacture date: part 202.878ts, lot 131p631: manufacturing site: (b)(4).Release to warehouse date: july 05, 2021.Expiration date: june 01, 2026.A manufacturing record evaluation was performed for the sterile lot number, and no non-conformances were identified.Device evaluated by mfr: a photo investigation was completed: analysis of the photo revealed that the screw had no defect found on it.The picture provided does not provide enough evidence in order to confirm the allegation.As the visual 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 not confirmed.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 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.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 cortscr ø2.7 self-tap l18 sst was broken from the threaded shaft, fragment was not returned.Embedded condition cannot be confirmed since x-ray evidence was not provided.A dimensional inspection for the cortscr ø2.7 self-tap l18 sst 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 cortscr ø2.7 self-tap l18 sst 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 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 CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14598000
• Report Number: 8030965-2022-03681
• Device Sequence Number: 17506183
• Product Code: HWC
• UDI-Device Identifier: 10886982145086
• UDI-Public: (01)10886982145086
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2026
• Device Model Number: 202.878
• Device Catalogue Number: 202.878TS
• Device Lot Number: 131P631
• 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: 05/06/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2021
• 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: VA-LCP CLAVICLE PLATE 2.7 LAT CS1 LE SST
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 16 YR
• Patient Sex: Male