MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED CONNECTING SCREW; ROD, FIXATION, INTRAMEDULLARY

Model Number 03.037.010

Device Problem Failure to Align (2522)

Patient Problem No Code Available (3191)

Event Date 06/07/2018

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.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.Reporter email address is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records review has been requested.(b)(4).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 during a trochanteric fixation nailing advance (tfna) procedure on (b)(6) 2018, the aiming arm and cannulated connecting screw misaligned, causing the distal screw to miss the tfna nail.The screw went through the protection sleeve.The surgeon removed the nail, tried a different nail and missed the nail again.The surgeon continued to implant the nail without the distal locking screw.It is unknown if there was a surgical delay.Patient outcome is unknown.Concomitant devices reported: complete radiolucent insertion handle (part: 03.037.012, lot: 8943792, quantity: 1).The 10 mm/130 degree titanium cannulated tfna 170 mm-sterile (part: 04.037.042s, lot: h517483, quantity: 1), screwdriver (part: unknown, lot: unknown, quantity: 1).This report is for a cannulated connecting screw.This is report 1 of 3 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.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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

Concomitant devices reported: complete radiolucent insertion handle (part: 03.037.012, lot: 8943792, quantity: 1); 10mm/130 degree titanium cannulated tfna 170mm-sterile (part: 04.037.042s, lot: h517483, quantity: 1), screwdriver (part: unknown, lot: unknown, quantity: 1); aiming arm locking device (part # 03.037.015, lot # l229022, quantity 1).

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.Part: 03.037.010; lot: 9343574; manufacturing site: haegendorf; release to warehouse date: march 31, 2015.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Customer quality investigation: the following investigations were performed: device interaction/ functional: device condition: the returned device was visually examined, and no visual defects were identified.All the devices that constitutes the nail implanting construct were not returned.Therefore, functional inspection on construct alignment and complaint condition replication was not possible at customer quality.However, no fit and alignment issues were identified on the returned portions of the devices when functionally inspected at customer quality (cq).Also, complaint condition replication was not possible as the mating device were not returned.Therefore, complaint condition was not able to be confirmed.However, to further determine the complaint condition for any issues unidentified during visual inspection; device dimensional analysis and device history record review was performed.Dimensional analysis and document/specification review: relevant drawings for the returned device were reviewed (both current revision and from the time of manufacture): connecting screw drawing.Dimensional analysis performed on the thread portion of the returned device measured the thread diameter as 10.85 mm (ca-814) that falls within the specifications of 10.8 mm to 11 mm, thread specifications, and tolerance specified.Review of the device history record showed that this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Furthermore, the risk document review performed during investigation showed that the risk document completely addresses the given complaint condition.No definitive root cause was able to be determined with the available returned devices.Conclusion: this complaint was not able to be confirmed and no product design issues or manufacturing discrepancies were identified during this investigation.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: CANNULATED CONNECTING SCREW
• 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: 7663585
• MDR Text Key: 113178490
• Report Number: 2939274-2018-52715
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070265
• UDI-Public: (01)10886982070265
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.037.010
• Device Catalogue Number: 03.037.010
• Device Lot Number: 9343574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Date Manufacturer Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THERAPY DATE: (B)(6) 2018; THERAPY DATE: (B)(6)
• Patient Outcome(s): Required Intervention