MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PERCUTANEOUS RADIOLUCENT INSERTION HANDLE; ROD, FIXATION, INTRAMEDULLARY

Model Number 03.037.112

Device Problems Failure To Adhere Or Bond (1031); Material Distortion (2977)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/12/2018

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.A device history record (dhr) review was performed for part no.: 03.037.112, lot no.: 9509681: manufacturing location: (b)(6), release to warehouse date: 25.Aug.2015: no non-conformance reports (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.A product investigation was performed on the subject device.Device condition: the insertion handle was received intact but with deformation of edges which connect with the mating nail.The deformation has resulted in raised edges at the two slotted openings and outward flaring of the ends.The tab component also showed an area of scraping and raised edges on the flats.Thus, the complaint condition is confirmed based on the observed damage.This deformation would result in interference with the connection to a mating nail.However, replication of the complaint condition is not applicable as the mating device was not received.Lot number review: the lot went through the required steps during the inspection at the time of manufacturing and the dhr records showed no issues concerning the material or material conditioning.Drawing review: based on the date of manufacture the relevant drawings, reflecting the current and manufactured revision, were reviewed.Due to the flared edges and deformation, the slot widths measured and found to be outside the required specification of per relevant drawings.Thus, accurate dimensional inspection of the slots could not be completed due to the observed damage.The tab width measured and is within the specification per relevant drawings.The design history was found to not impact the complaint condition as the only change concerned adding udi marking to the product.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: a device history record (dhr) review, device inspection and drawing review were performed as part of this investigation.The complaint condition is confirmed based on the observed deformation.No definitive root cause of the initial deformation was able to be determined as circumstances surrounding the event are unknown.However, there is no indication that a design or manufacturing issue contributed to the complaint.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 reported that during a procedure for hip fracture on (b)(6) 2018, a percutaneous radiolucent insertion handle would not get connected with a ti cannulated trochanteric fixation nail-advanced (tfna) nail.As the surgeon was struggling to get the nail connected to the handle, the nail dropped on the ground (nail was intact).Another tfna nail was available for completion of the surgery.As the percutaneous radiolucent insertion handle was not functioning correctly, a standard insertion handle was used in place of the percutaneous radiolucent insertion handle and the surgery was successfully completed without any surgical delay.The patient was stable after the surgery.During manufacture¿s investigation of the returned subject device, it was identified that the insertion handle was received intact but with deformation of edges which connect with the mating nail.The deformation has resulted in raised edges at the two slotted openings and outward flaring of the ends.The tab component also showed an area of scraping and raised edges on the flats.This condition was re-evaluated and determined to be reportable on march 12, 2018.Concomitant devices reported: 12mm/130 deg ti cann tfna 170mm - sterile (part # 04.037.242s, lot # h472668, qty # 1).This is report 1 of 1 for complaint (b)(4).

• Brand Name: PERCUTANEOUS RADIOLUCENT INSERTION HANDLE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7332431
• MDR Text Key: 102910674
• Report Number: 2939274-2018-51011
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070562
• UDI-Public: (01)10886982070562(10)9509681
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.037.112
• Device Catalogue Number: 03.037.112
• Device Lot Number: 9509681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2015
• 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 Age: 90 YR
• Patient Weight: 95