MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAILS-STER; SCREW, FIXATION, BONE

Model Number	04.005.426S
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown when the screw bent; it was noted that on (b)(6) 2018 it was discovered bent.Additional product code: hsb.Device has not been reported as explanted.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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) 2018 during an intramedullary (im) nailing procedure of the right tibia for a fractured tibia, it was discovered that a locking screw was bent.The screw was used and implanted in the patient.There was no surgical delay.There were no reported surgical and patient outcomes.This is report 1 of 1 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.Device history record (dhr) review: item: 04.005.426s; lot: h323031; mfg date: 23 mar 2017; mfg qty: 139; manufacturer: monument; exp date: 28 feb 2026; all inspections were performed and passed per inspection sheet.No reworks or nonconformances (ncs) were generated during the production of this lot.Sterigenics provided a certificate of processing and dosimetry report certifying that the product was sterilized per requirements.No nonconformance records (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAILS-STER
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7596674
• Report Number: 2939274-2018-52489
• Device Sequence Number: 16499385
• Product Code: HWC
• UDI-Device Identifier: 10886982085399
• UDI-Public: (01)10886982085399
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K103002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2018

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 Expiration Date: 02/28/2026
• Device Model Number: 04.005.426S
• Device Catalogue Number: 04.005.426S
• Device Lot Number: H323031
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2018
• Supplement Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR