MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DHS®/DCS® COUPLING SCREW; EXTRACTOR

Catalog Number 338.31

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/11/2017

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.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.(b)(6).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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that a hip thinning procedure was conducted for a hip fracture on (b)(6) 2017 and the tip of one (1) dhs®/dcs® coupling screw broke inside an unknown dhs plate during the surgery and was retained in the patient.The plan was to implant one (1) unknown dhs plate with one (1) unknown dhs lag screw into the patient.While the surgeon was screwing the dhs lag screw into the femoral neck, upon turning the screw, the tip of the coupling screw snapped off and was stuck inside the dhs lag screw and the surgeon decided to leave the tip inside the dhs lag screw.There was no other complication during the surgery and no additional interventions were required.The procedure was completed successfully without any surgical delay and the patient was reported to be in stable condition.Concomitant devices reported: unknown dhs plate (part # unknown, lot # unknown, quantity # 1), unknown dhs lag screw (part # unknown, lot # unknown, quantity # 1).This report is for one (1) dhs®/dcs® coupling screw.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

Dhr review was completed.Part number: 338.31 , synthes lot number: 5041472 , supplier lot number: n/a , release to warehouse date: 29-jul-2005 , expiration date: n/a , manufactured by synthes (b)(4).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Customer quality conducted an investigation of the returned device.Device condition: the coupling screw (part 338.31, lot 5041472, mfg 29-jul-2005) was received at us cq with a sheared off distal tip.Fragments were not returned.The complaint condition was visually confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the devices were returned broken lot number review: dhr review showed no ncr¿s were generated during production.The material, and material properties of the returned part were determined to be conforming at the time of manufacture based on review of the dhr(s).Drawing review: the following drawing(s) was reviewed; --dhs/dcs coupling screw: (current) and (mfg) dimensional analysis was completed, the inner diameter of shaft at the distal end, measured 2.70 mm.This is within specification of 2.60 to 2.75 mm, based on drawing.The outer diameter of shaft at the distal end, measured 4.01 mm.This is within specification of 3.97 to 4.05 mm, based on drawing.Conclusion: the complaint condition is confirmed as the coupling screw (part 338.31, lot 5041472) was received broken.A device inspection and drawing review were performed as part of this investigation.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces (such as off axis).No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.The dynamic hip plating implants - core dossier design and clinical risk management (dcrm) document was reviewed and found to adequately address the harm of this complaint condition.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® COUPLING SCREW
• Type of Device: EXTRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7176132
• MDR Text Key: 96810270
• Report Number: 2939274-2018-50137
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10886982193322
• UDI-Public: (01)10886982193322(10)5041472
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 338.31
• Device Lot Number: 5041472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 01/09/2018
• Supplement Dates Manufacturer Received: 01/10/2018; 03/08/2018
• Supplement Dates FDA Received: 01/12/2018; 03/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention