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

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 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).

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
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7596674
• MDR Text Key: 111023466
• Report Number: 2939274-2018-52489
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982085399
• UDI-Public: (01)10886982085399
• Combination Product (y/n): N
• PMA/PMN Number: K103002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 04.005.426S
• Device Catalogue Number: 04.005.426S
• Device Lot Number: H323031
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2018
• Initial Date FDA Received: 06/13/2018
• Supplement Dates Manufacturer Received: 06/21/2018
• Supplement Dates FDA Received: 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 15 YR