MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM FLEXIBLE SHAFT; REAMER

Catalog Number 352.040

Device Problem Device Issue (2379)

Patient Problem No Code Available (3191)

Event Date 01/27/2018

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Date returned to manufacturer.Patient code (b)(4) used for: the complainant indicated that the drill bit broke intra-operative and a non-implant grade fragment is retained in the patient.Device history records review was conducted.The report indicates that the: dhr review: ip-00138211 5.0mm flexible shaft part: 352.040 lot: 2748586 manufacturing site: (b)(4).Release to warehouse date: 27.June 2011 no ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.

Event Description

It was reported that during a procedure for implanting a synthes lateral entry recon nail on (b)(6) 2018, a 4.5mm/6.5mm stepped drill bit large qc/485mm would not pass through the protection sleeves and the nail as it should.During this process, the drill bit broke inside of the patient bone.The broken fragment of the drill bit was retrieved and nothing was left in the patient.Also, a recon locking aiming arm for lateral entry femoral nails-ex was not working properly as it was misaligned with nail, but prior to insertion of femoral neck/head component, nail connection was checked and the aiming arm connection was secured as well.Two of the 11.5mm/8.5mm protection sleeve for recon locking and two 8.5mm/3.2mm wire guide for recon locking were also not guiding the drill bit properly through the nail.A standard insertion handle connected with the aiming arm wasn't working properly as the sales consultant heard some noise when the handle was being used.A cannulated connecting screw for standard insertion handle was not getting connected properly and a 5.0mm flexible shaft was not able to pass over a 2.5mm reaming rod.There was a surgical delay of 30 minutes and the surgeon was unable to implant recon screws into proximal femur.To complete the surgery, the surgeon opted to lock in dynamic hole by using a regular 4.9mm locking volt.The surgery was completed and the patient was stable after the surgery.This complaint involves six (6) devices.This report is 6 of 6 for (b)(4).

Manufacturer Narrative

Dhr review was completed part: 352.040 lot: 2748586 manufacturing site: bettlach release to warehouse date: 27.June 2011 no ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.H3, h6: customer quality conducted an investigation of the returned device.Device condition: the 5.0mm flexible shaft was received intact with surface wear consistent with use and which would not impact the functionality.No damage to the cannulation was observed and no retained debris was noted.The device cannulation was inspected in the ¿drawing review¿ section below and no discrepancies were observed.Thus, as no functional or dimensional issue was identified, the complaint condition for this device is unconfirmed and could not be replicated.Lot number review: review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.Release to warehouse date: 27.June 2011 drawing review: based on the date of manufacture the drawings reflecting the current and manufactured revision, were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The cannulation narrows in the proximal coupling component.This location accepted a best fit gage pin of 2.78mm which is within the specification of 2.8mm +/-0.05 the cannulation also narrows in the distal coupling component.This location accepted a best fit gage pin of 2.78mm which is within the specification of 2.8mm +/-0.05 no definitive root cause was able to be determined as no product issues were identified with the 5.0mm flexible shaft and the specific intraoperative condition which result in this condition are unknown.Conclusion: a device history record (dhr) review, device inspection, and drawing review were performed as part of this investigation.The complaint condition is unconfirmed as no issues were identified with the returned device.There is no indication that a design or manufacturing issue contributed to the complaint.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.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

Additional narrative: the device was received and the product evaluation is in progress.No conclusion can be drawn.Corrected data: these dates were reported as (b)(6) 2018 in the initial report (b)(4) in error.The correct date is (b)(6) 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: 5.0MM FLEXIBLE SHAFT
• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7293462
• MDR Text Key: 101145147
• Report Number: 2939274-2018-50760
• Device Sequence Number: 1
• Product Code: HTO
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2018

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: 352.040
• Device Lot Number: 2748586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Initial Date Manufacturer Received: 01/28/2018
• Initial Date FDA Received: 02/23/2018
• Supplement Dates Manufacturer Received: 02/28/2018; 03/28/2018
• Supplement Dates FDA Received: 02/28/2018; 03/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0656-2017
• Patient Sequence Number: 1