MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/110MM; APPLIANCE,FIXATION,NAIL

Model Number	280.310
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional pro codes: jdo.(b)(4).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
Event or Problem Description
It was reported that on (b)(6) 2019, the patient underwent a revision procedure due to a nonunion and a broken lag screw.Initially the patient had an open reduction internal fixation (orif) for an intertrochanteric fracture using with a 4 hole dynamic hip system (dhs), one 12.7mm lag screw and three 4.5mm cortex screws in (b)(6) 2018.However, on an unknown date, the patient was found to have a non-union of the intertrochanteric fracture and breakage of the 12.7mm lag screw at the medial tip of the dhs side plate barrel.Thus, a revision procedure was done wherein all the existing implants and fragments were removed uneventfully.Then, the patient was revised with a 95-degree blade plate (9 hole shaft - 80mm blade length) and five 4.5 cortex screws.It is unknown if there was a surgical delay.Patient status is unknown.Concomitant device reported: dhs plate (part # 281.140, lot # 9323622, quantity 1), cortex screw (part # 214.840, lot # unknown, quantity 3).This complaint involves one (1) device.This report is for one (1) dhs®/dcs® one-step lag screw 12.7mm thread/110mm this is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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 history lot part number: 280.310, lot number: h599550, part manufacturing date: 29 march 2018, manufacturing site: elmira, part expiration date: n/a, nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot h599550 of dhs/dcs one-step lag screws was processed through the normal manufacturing and inspection operations with no rework or non-conformances noted.This 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.A review of the raw material device history record(s) determined the raw material lot h589186 met all specifications with no issues documented that would contribute to this complaint condition.A review of the device history record revealed no complaint related anomalies.This 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.Investigation summary background: it was reported that on (b)(6) 2019, the patient underwent a revision procedure due to a nonunion and a broken lag screw.Initially the patient had an open reduction internal fixation (orif) for an intertrochanteric fracture using with a 4 hole dynamic hip system (dhs), one lag screw and three cortex screws in (b)(6) 2018.However, on an unknown date, the patient was found to have a non-union of the intertrochanteric fracture and breakage of the 12.7mm lag screw at the medial tip of the dhs side plate barrel.Thus, a revision procedure was done wherein all the existing implants and fragments were removed uneventfully.Then, the patient was revised with a 95 degree blade plate (9 hole shaft - 80mm blade length) and five 4.5 cortex screws.It is unknown if there was a surgical delay.Patient status is unknown.Concomitant device reported: dhs plate (part # 281.140, lot # 9323622, quantity 1), cortex screw (part # 214.840, lot # unknown, quantity 3).This complaint involves one (1) device.Investigation flow: damage visual inspection: the dhs®/dcs® one-step lag screw 12.7mm thread/110mm (part # 280.310 lot # h599550) was returned and received at the us cq.Upon visual inspection, it was observed that the device was broken into two pieces.Both pieces were returned to the us cq.No other issues were identified with the returned portions of the device.The received condition is consistent with the complaint condition thus conforming the complaint.Dimensional inspection: conclusion: the measuring result does show conformity.Document/ specification review: the following drawing(s) was reviewed: dhs one step lag screw, 280_251 rev j a manufacturing record evaluation revealed no complaint related anomalies.This 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.Investigation conclusion: a definitive assignable root cause for the post manufacturing damage could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified because of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.Part manufacturing date: march 29, 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: DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/110MM
• 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: 9182872
• Report Number: 2939274-2019-61476
• Device Sequence Number: 2568789
• Product Code: KTT
• UDI-Device Identifier: 10886982175250
• UDI-Public: (01)10886982175250
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K964259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2019

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
• Operator of Device: Health Professional
• Device Model Number: 280.310
• Device Catalogue Number: 280.310
• Device Lot Number: H599550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 10/07/2019; 11/08/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 11/06/2019; 11/12/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 135 DEG DHS® PLATE-STANDARD BARREL 4 HOLES/78MM; 4.5MM CORTEX SCREW SELF-TAPPING 40MM; 4.5MM CORTEX SCREW SELF-TAPPING 40MM; 4.5MM CORTEX SCREW SELF-TAPPING 40MM
• Outcome Attributed to Adverse Event: Required Intervention