MAUDE Adverse Event Report: SYNTHES ELMIRA DHS®/DCS® LAG SCREW 12.7MM THREAD/100MM; APPLIANCE,FIXATION,NAIL

Catalog Number	280.000
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional patient identifier: (b)(6).(b)(4) patient¿s weight is unknown.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.A device history record (dhr) review was performed for part # 280.000, lot # h113962: release to warehouse date: 02 june 2016, manufacturing site: (b)(4): 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/ 100mm product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.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 with no non-conformance noted.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.The 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 or Problem Description
It was reported that the surgeon was performing a hip fracture surgery with synthes dynamic hip system (dhs) on (b)(6) 2017.He experienced difficulty placing the dhs side plate over the just implanted synthes lag screw.After struggling for some time, he removed the lag screw and extra-operatively discovered the lag screw did not fit through the barrel of the side plate.Other lag screws from the set were tested and fit fine.The explanted lag screw was trialed through a different side plate and did not fit.There were no fragments generated while the lag screw was being explanted.No unanticipated x-rays were taken.The surgeon then implanted a lag screw from a second set, slid the side plate over the lag screw and the procedure was completed without any incident.Patient's outcome is unknown.There was a forty (40) minute delay in surgery.Concomitant device reported: side plate (part # unknown, lot # unknown, quantity 1) this report is for one (1) dhs®/dcs® lag screw.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Product development investigation was completed.A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation.This complaint was unable to be confirmed at cq as the plate was not returned.Only the lag screw was returned to the manufacturer.The returned screw is damaged on the proximal end.The damage is post manufacturing damage (proximal end is splayed out).The complaint was not able to be replicated at customer quality (cq) as the side plate was not returned to cq.Tabulated drawing for the family of dhs/dcs screws was reviewed during this investigation.No product design issues or discrepancies were observed.The complaint condition was most likely caused by attempting to force the plate over the already implanted lag screw.Per the dhs/dcs dynamic and condylar screw system technique guide, prior to implanting the lag screw, the user needs to insert the coupling screw into the one-step wrench and slide the dhs plate onto the shaft of the wrench.Then select the appropriate length lag screw and place on the end of the wrench and then insert the lag screw into the bone.No new, unique or different patient harms were identified as a result of this evaluation.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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® LAG SCREW 12.7MM THREAD/100MM
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6610816
• Report Number: 3003506883-2017-10101
• Device Sequence Number: 18834927
• Product Code: KTT
• UDI-Device Identifier: 10886982174871
• UDI-Public: (01)10886982174871(10)H113962
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K791619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2017

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 Catalogue Number: 280.000
• Device Lot Number: H113962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2017
• Supplement Report FDA Received Date: 06/22/2017
• Patient Sequence Number: 1
• Patient Age: 50 YR