MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM F/IM NAIL-STER; SCREW, FIXATION, BONE

Model Number	04.005.530S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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
It was reported that on (b)(6) 2021, the patient underwent re-operation due to being non-compliant with the physician's instructions which resulted in a non-union fracture.Titanium cannulated tibial nail and four (4) locking screws will be removed.There was patient consequence reported.This report is for one (1) 5.0mm ti locking screw w/t25 stardrive 40mm f/im nail-ster this is report 3 of 5 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H10 additional narrative: h3, h6: investigation summary investigation flow: adverse event.Visual inspection: the 5.0 ti lckng screw t25 sd 40 f/im nail-s (p/n: 04.005.530s, lot number: 97p1027) was received at cq west chester for investigation.Visual inspection of the complaint device showed no damage or defects with the complaint device.Device failure/defect was not identified.Investigation conclusion: the complaint is not confirmed as no issues were identified on the complaint device that would contribute to the adverse event.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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 lot manufacturing location: monument manufacturing date: 30-mar-2021.Expiration date: 28-feb-2031.Part number: 04.005.530s, 5.0mm ti locking screw w/t25 stardrive 40mm f/im nail ¿ sterile.Lot number: 97p1027 (sterile).Lot quantity: (b)(4).Four pieces were scrapped in cell at op #60, final inspection, for discolored surface finish.Production order traveler met all inspection acceptance criteria apart from the four pieces noted.Inspection sheet, whirl threads, vibe, flute / final inspection, ns053611 rev l met all inspection acceptance criteria apart from the four pieces noted.Packaging label log (pll) lppf rev e, lmd rev a was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 19698 supplied by sterigenics was reviewed and determined to be conforming.This lot met all dimensional, visual, sterilization and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component(s) reviewed: part number: 04.005.530.999, 5.0mm ti screw blank 40mm 05.0 nail lock screw w/sd25.Lot number: 87p0813.Lot quantity: (b)(4).Ninety pieces were scrapped in cell at op #10, warm head blank, ten due to a machine warm-up issue and eighty due to taper depth being too deep.Production order traveler met all inspection acceptance criteria apart from the ninety pieces noted.Part number: 23020, tialnbci4.98.Lot number: 11l9988.Lot quantity: (b)(4) lbs.Inspection instruction met all inspection acceptance criteria.Certified test report supplied by (b)(4) dated 08-jul-2019 was reviewed and determined to be conforming.Lot summary report dated 09-sep-2019 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.Device history review 30-sep-2021: dhr reviewed.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: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM F/IM NAIL-STER
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12666274
• Report Number: 2939274-2021-06196
• Device Sequence Number: 14572642
• Product Code: HWC
• UDI-Device Identifier: 10886982085993
• UDI-Public: (01)10886982085993
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K000089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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: 04.005.530S
• Device Catalogue Number: 04.005.530S
• Device Lot Number: 97P1027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• 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: 12 TI CANN TIB NAIL-EX PROX BEND 375-S; 5.0 TI LCKNG SCREW T25 SD 36 F/IM NAIL-S; 5.0 TI LCKNG SCREW T25 SD 38 F/IM NAIL-S; 5.0 TI LCKNG SCREW T25 SD 46 F/IM NAIL-S; 12 TI CANN TIB NAIL-EX PROX BEND 375-S; 5.0 TI LCKNG SCREW T25 SD 36 F/IM NAIL-S; 5.0 TI LCKNG SCREW T25 SD 38 F/IM NAIL-S; 5.0 TI LCKNG SCREW T25 SD 46 F/IM NAIL-S
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 102 KG