MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM / TI CANN FRN / GT 400MM / RIGHT ¿ STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.033.070S

Device Problem Use of Device Problem (1670)

Patient Problem Not Applicable (3189)

Event Date 06/28/2018

Event Type  Injury  

Manufacturer Narrative

Device was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.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.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 patient underwent a procedure to implant a 10mm cannulated femoral recon nail (frn) on (b)(6) 2018.During the procedure, the nail became lodged in the patient¿s proximal femur, as the opening reamer of the nail did not allow for the nail to be fully inserted.Surgeon attempted to back the nail out but was not successful.Surgeon was forced to proceed with insertion of the nail and was eventually able to seat the nail, but only low enough to allow for one (1) proximal femoral recon screw to be implanted.Surgeon was then able to use the nail¿s distal locking options to complete the procedure with a delay of approximately 60 minutes.This report is for one (1) 10mm cannulated frn nail.This is report 1 of 1 for (b)(4).

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.Additional narrative: event: additional information provided.Lot number is now known.Part: 04.033.070s; lot: l828180; manufacturing site: bettlach; release to warehouse date: april 06, 2018; expiry date: february 28.2028.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all material, dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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

The surgeon reamed with a 14mm cannulated opening reamer for the proximal diameter of the nail.Then we reamed up to a 12mm for a 10mm nail.

Event Description

Further it was reported that one of the proximal recon screws was unable to be implanted due to the height of the nail in the femur.Here was no adverse effect on the patient reported.Concomitant devices reported: titanium recon screw (part#-04.003.031s, lot#-unknown, quantity 1), titanium recon screw (part#-04.005.534s, lot#-unknown, quantity 1), titanium recon screw (part#-04.005.540s, lot#-unknown, quantity 1).

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.Expiration date.Added concomitant devices and therapy date.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: 10MM / TI CANN FRN / GT 400MM / RIGHT ¿ STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7716182
• MDR Text Key: 114934363
• Report Number: 2939274-2018-53066
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982272027
• UDI-Public: (01)10886982272027
• Combination Product (y/n): N
• PMA/PMN Number: K172157
• 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: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.033.070S
• Device Catalogue Number: 04.033.070S
• Device Lot Number: L828180
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR
• Patient Weight: 60