MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DHS/DCS-SCR Ø12.5 L110 SST; APPLIANCE,FIXATION,NAIL

Model Number	280.100
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A review of the device history records has been requested.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.
Event or Problem Description
Synthes canada reports an event in (b)(6) as follows: it was reported that during a dynamic hip screw (dhs) procedure on (b)(6) 2018, a dynamic hip screw/dynamic condylar screw (dhs/dcs) plate would not slide over the dynamic hip screw/dynamic condylar screw (dhs/dcs) lag screw.Other screws were tested without a problem.Another dhs/dcs lag screw was readily available and was used to complete the surgery with a delay of approximately 5 minutes.No patient consequence reported.Surgical outcome is unknown.Concomitant device reported: dhs/dcs plate (part number unknown, lot number unknown, quantity 1).This report is for one (1) dhs/dcs lag screw.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.The device was received, and the product evaluation is in progress.No conclusion can be drawn.Additionally, device history records 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.
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.Part: 280.100; lot: 4812374; date of manufacture: july 30, 2004; place of manufacture: elmira.Description of the device history record (dhr) review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of dhs/dcs lag screw 12.7mm thread/110mm non-sterile product was processed through the normal manufacturing and inspection operations.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Customer quality investigation: the following investigations were performed: device interaction/ functional and damage-visual appearance not as expected: device condition: visual inspection performed at customer quality (cq) on the received lag screw showed no visual defects.Functional inspection: functional test was not able to be performed as the mating plate was not returned.Also, the complaint condition was not able to be replicated.However, further evaluation including drawing review, dimensional analysis, device history record review was performed during investigation to evaluate any potential issues that could have contributed to complaint condition.Dimensional analysis and document/specification review: relevant drawings for the returned instrument were reviewed (both from the time of manufacture and present revision) and no design issues were noted: dhs lag screw dimensional inspection was performed on the relevant dimensions and the measurements were obtained as below per drawing: dimensional analysis performed on the proximal head diameter measured the maximum diameter as 12.584 mm (om803) that falls within the specification of 12.5 mm to 12.7 mm.Internal cannulation measured the diameter as 5.05 mm (ca-814) that falls within the specification of 4.95 mm to 5.1 mm.U-shaped cannulation at the distal thread measured the width as 2.7 mm (ca-814) that falls within the specification of 2.6 mm to 2.7 mm.Internal thread diameter at the distal cannulation accepted the max diameter as 3.41 mm (gp:29) that falls within the specification of 3.242 mm to 3.422 mm.Flat to flat diameter at the proximal thread measured the diameter as 7.1 mm(ca-814) that falls within the specification of 7.1mm to 7.15 mm.Lastly, the curvature diameter measured the diameter as 7.87 mm (ca-814) that falls within the specification of 7.85 mm to 7.9 mm.No design issues were identified on relevant dimensions of the device critical to quality.Review of the device history record showed that this lot of dhs/dcs lag screw 12.7 mm met all dimensional, visual and packaging criteria at the time of release with no issues documented.Furthermore, review of the raw material device history record revealed no issues relevant to complaint condition.Conclusion: a definitive root cause could not be determined from the provided information.However, any possible misalignment could have contributed to this complaint condition.The complaint condition was not able to be confirmed.However, 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.
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 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: DHS/DCS-SCR Ø12.5 L110 SST
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7821997
• Report Number: 2939274-2018-53505
• Device Sequence Number: 19118379
• Product Code: KTT
• UDI-Device Identifier: 10886982174918
• UDI-Public: (01)10886982174918
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K791619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/07/2018

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: 280.100
• Device Catalogue Number: 280.100
• Device Lot Number: 4812374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 08/28/2018; 08/29/2018; 09/28/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 08/29/2018; 09/24/2018; 10/02/2018
• Patient Sequence Number: 1