MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC EXTRACTSCR F/AFN/DFN; EXTRACTOR

Catalog Number 357.133

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2018

Event Type  malfunction  

Manufacturer Narrative

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.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient was implanted with an unknown synthes tibial nail on an unknown date approximately 14 years ago.On (b)(6) 2018, the patient was returned to the operating room to remove the device.During the procedure, the threads on the endcap of the nail were stripped and the surgeon was unable to attach the proper extraction instrument.In attempting to extract the nail, a synthes cannulated connecting screw and extraction screw were both damaged.Due to the damage to the nail, the surgeon was unable to extract the nail and could not complete the procedure.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A device history record review (dhr) was performed for the subject device: part no.: 357.133.Lot no.: l000512.Manufacturing location: (b)(4), release to warehouse date: 31.Aug.2016.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No nonconformances (ncrs) were generated during production.A product development investigation was performed for the subject device: it was reported that a patient was implanted with an unknown synthes tibial nail on an unknown date approximately 14 years ago.On (b)(6) 2018, the patient was returned to the operating room to remove the device.During the procedure, the threads on the endcap of the nail were stripped and the surgeon was unable to attach the proper extraction instrument.In attempting to extract the nail, a synthes cannulated connecting screw and extraction screw were both damaged.Due to the damage to the nail, the surgeon was unable to extract the nail and could not complete the procedure.The returned extraction screw was examined and the complaint condition was able to be confirmed as the distal threaded tip was found to be deformed.The complaint condition was unable to be replicated due to post-manufacturing damage.The returned extraction screw was manufactured in aug 2016.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr.Relevant drawings for the returned device were reviewed (both current revision and from the time of manufacture): top-level.The design, materials and finishing processes were found to be appropriate for the intended use of this device.The extraction screw for ti femoral and tibial nails (357.133) is a common trauma instrument, noted in approximately eleven (11) nail system technique guides including: titanium cannulated tibial nails system, adolescent lateral entry femoral nail system and titanium retrograde/antegrade femoral nail system.In each instance the extraction screw is available if implant removal is desired.The extraction screw is threaded into the implanted nail and a hammer guide is attached to the extraction screw allowing for implant removal with light hammer blows.A dimensional inspection was not able to be performed at customer quality (cq) because of the post manufacturing damage.No definitive root cause could be determined; the failure mode is typically associated with attempted off-axis insertion leading to thread deformation.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.

Event Description

It was noted that the removal of the device was at the request of the patient for an unknown reason.The damage to the cannulated connecting screw and extraction screw was damaged threads on both devices.

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.H10 additional narrative: b5, d4: lot and udi number, d10.H3, h6: 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.

• Brand Name: EXTRACTSCR F/AFN/DFN
• Type of Device: EXTRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7328163
• MDR Text Key: 102103426
• Report Number: 2939274-2018-50978
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10886982195883
• UDI-Public: (01)10886982195883(10)LOTUNKNOWN
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 02/09/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 357.133
• Device Lot Number: L000512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Initial Date Manufacturer Received: 02/09/2018
• Initial Date FDA Received: 03/09/2018
• Supplement Dates Manufacturer Received: 04/20/2018; 05/04/2018
• Supplement Dates FDA Received: 04/23/2018; 05/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1