MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 48MM F/IM NAILS-STER; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.005.438S

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during a suprapatellar tibial nail surgery, one (1) 4mm x 48mm locking screw bent intra-operatively, the surgeon had difficulty removing one (1) connecting screw and (1) ball hex t-handle from one (1) tibial nail.It was reported that the 4mm x 48mm locking screw was bent while in the compression locking mode in the dybanic screw hole.The bent screw was removed and replaced with another similar screw.At the end of the surgery, while attempting to remove the connecting screw and ball hex t-handle, the surgeon faced some difficulty in doing so.It was later discovered that the ball hex t-handle seems to strip and skip out of the connecting screw upon unscrewing counterclockwise.The surgeon was eventually able to remove the connecting screw and the ball hex t-handle from the tibial nail.The outcome of the procedure is currently unknown.This complaint involves two (2) devices.Concomitant devices reported: unknown tibial nail (part# unknown, lot# unknown, quantity# 1), dybanic screw (part# unknown, lot# unknown, quantity# 1).This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Lot number is unknown.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.A product investigation was performed.Based on measurements and complaint description the unknown screw is most likely part number 04.005.438(s).The returned 4.0mm locking screw is included in a variety of trauma systems related to intramedullary nailing, including the titanium cannulated humeral nail system (dsus/trm/0916/1036).The returned implant was received bent off of its shaft, which confirmed the complaint condition, although it had not broken into two separate pieces.Based on visual inspection of the screw, the complaint condition was confirmed, and its replication is inapplicable.The returned 4.0mm locking screw did not have a lot number etched on it, so its dhr review could not be performed, and its date of manufacture is unknown.Relevant drawings for the returned instrument were reviewed (current only due to unk mfg date): 04_005_408 (rev f).No design issues or discrepancies were identified.Measurements (04_005_408 (rev f)): screw head diameter: ø7.7 to 8.1 mm (measured: 7.89 mm), threaded shaft diameter: ø3.95 max (measured:3.86 mm), length: 48.00-48.70 mm (measured: 48.49 mm), a root cause could not be determined as the circumstances surrounding the complaint are unknown.The measurements of the returned damaged screw indicated that it was manufactured according to specifications, and further strengthened the reasoning that the complaint condition occurred due to unintended forces applied by the surgeon and therefore no material or hardness testing is required.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Calipers ca818 used for all measurements.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.

Manufacturer Narrative

Additional narrative: additional device product code: hwc.Date of initial implant is unknown.See description in initial report (b)(4); therapy date: (b)(6) 2018.The device was received and the product evaluation is in progress.No conclusion can be drawn.Corrected data: report, return dates: these dates were incorrectly reported as 1/10/2018 in initial report (b)(4).The correct date is 1/9/2018.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 48MM F/IM NAILS-STER
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7246293
• MDR Text Key: 99205834
• Report Number: 2939274-2018-50530
• Device Sequence Number: 1
• Product Code: HSB
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.005.438S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Date Manufacturer Received: 04/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1