MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM F/IM NAIL-STER; SCREW, FIXATION, BONE

Model Number	04.005.522S
Medical Device Problem Codes	Failure to Cut (2587); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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.A device history record review 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 during a tibial nail case procedure on (b)(6) 2018, the fully threaded non-self tapping screw did not go into the nail.The surgeon tried several times to get the titanium (ti) locking screw to go in, then pulled it out and noticed that it was not a self-tapping screw which they normally use.The procedure was successfully completed with a surgical delay of 5 minutes.Patient status was good.This report is for a 5.0mm ti locking screw 32mm.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.Manufacturing location: monument; manufacturing date: august 16, 2018; expiration date: july 31, 2027; part: 04.005.522s; 5.0mm ti locking screw w/t25 stardrive 32mm f/im nail sterile; lot: h699716 (sterile); lot quantity 102.Work order traveler met all inspection acceptance criteria.Eighteen pieces were scrapped in cell at final inspection for surface finish discoloration.Inspection sheet, whirl threads, vibe, flute / final inspection met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom for this lot was reviewed and found to be conforming with no deviations to normal packaging identified.Sterilization control number (scn) 15398 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: 04.005.522.999; 5.0mm ti screw blank 32mm 05.0 nail lock screw w/sd25; lot: h621385; lot quantity: 485 work order traveler met all inspection acceptance criteria.The provided photograph shows a locking screw.There are no visual issues observed with the screw; however, some blood from the procedure is present.The complaint regarding the screw being unable to advance could not be confirmed based on the photograph.The device being unable to cut is expected for this device as it is not a self-tapping screw.No packaging was photographed therefore, there is no way to determine if the issue is caused by an error in choosing the screw or if a packaging error existed.Based on review of the device history record (dhr) there is no indication of any manufacturing issues which would contribute to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 32MM 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
• MDR Report Key: 8039372
• Report Number: 2939274-2018-54812
• Device Sequence Number: 13819152
• Product Code: HWC
• UDI-Device Identifier: 10886982085917
• UDI-Public: (01)10886982085917
• Combination Product (Y/N): N
• Initial Reporter State: MO
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2018

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 Model Number: 04.005.522S
• Device Catalogue Number: 04.005.522S
• Device Lot Number: H699716
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 12/17/2018
• Patient Sequence Number: 1
• Patient Age: 71 YR