MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA BLADE PERF L105 TAN; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.027.036S

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.(b)(6).A device history record review was performed for part # 04.027.036s, lot # l024138: manufacturing location: (b)(4), manufacturing date: 16-jun-2016, expiry date: 01-jun-2026: 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.Subject device has been received and is currently in the evaluation process.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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during proximal femoral nail antirotation (pfna) surgery performed on (b)(6) 2016 it was difficult to lock the proximal femoral antirotate blade (pfna).When the blade was locked the gap was closed but then it was very difficult to get the impactor free from the blade.When they got the impactor free, the gap in the pfna blade was open and indicated that the blade was unlocked.The surgeon removed the blade and used another one.The surgery was prolonged to an unknown time.The procedure was successfully completed.No information available about patient condition and outcome.Concomitant medical products: unknown impactor (part# unknown, lot # unknown, quantity 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: a product investigation was completed: the investigation of the returned blade has shown damages inside the hexagon.A functional test was performed and has shown that the blade could be locked and unlocked without any problems.Also the inserter could be inserted and removed without any problems.The reported problem could not be replicated.The device history record was researched, no abnormal findings were identified.There were no issues during the manufacturing of the product that would contribute to this complaint condition.The visible damages inside the hexagon are looking as if the inserter was not in the right position while insertion.It looks like a shifted hexagon.Due to the damages inside the hexagon, it is likely that the impactor was not connected accordingly and has caused the problem.Due to the deformation of the blade it cannot be excluded that the used instrument is also damaged.No product fault could be detected.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: PFNA BLADE PERF L105 TAN
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6171604
• MDR Text Key: 62389785
• Report Number: 9612488-2016-10509
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2016

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: 04.027.036S
• Device Lot Number: L024138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2016
• Initial Date FDA Received: 12/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ONE (1) UNKNOWN IMPACTOR