MAUDE Adverse Event Report: SYNTHES HAGENDORF PERIARTICULAR AIMING ARM FOR 4.5MM LCP PROX TIBIA PL-RT; GUIDE

Catalog Number 03.120.001

Device Problems Nonstandard Device (1420); Malposition of Device (2616)

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

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: event date: unknown.Device is an instrument and is not implanted/explanted.Manufacturing location: (b)(4).Manufacturing date: 11february2008.No anomalies were detected during device history record review.No non-conformance reports 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.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 it was discovered during normal preventative maintenance by reporter that two (2) periarticular aiming arms and two (2) periarticular insertion handles no longer line-up correctly with the implants.No patient or procedure was involved in this event.This is report 2 of 4 for (b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

An investigation summary was performed.The investigation of the complaint articles has shown that: the complaint description indicated that the complaint condition was discovered during normal preventative maintenance.There is no information available which can assist in determining a definitive root cause.Based on the way the returned parts are used and the damage sustained by the parts, it is likely that the damage occurred due to wear from years of use and/or the accumulation of excessive force used during procedures.Based on the damage noticed on the returned insertion handles it is possible that they could have contributed to the complaint condition.The damage sustained by the insertion handles seems to indicate that they were exposed to unintended forces which subsequently caused them to become malformed and prevented them from precisely aligning with plates as intended.By reporter that two (2) periarticular aiming arm and two (2) periarticular insertion handles no longer line-up correctly with the implants.No patient or procedure was involved in this event.The returned parts are used in the 4.5mm lcp proximal tibia and 4.5 lcp condylar plate aiming instruments systems (j8240-c and j8241-c) to facilitate percutaneous sub muscular insertion of plates.The returned right periarticular aiming arm (03.120.001, 1810704) was received with minor damage indicative of routine use.The returned right periarticular insertion handle (03.120.002, 1829296) was received with significant wear which could potentially impact alignment and contribute to the complaint condition.The returned left periarticular aiming arm (03.120.004, 1802319) was received with minor damage indicative of routine use.The returned left periarticular insertion handle (03.120.005, 1797331) was received with significant wear which could potentially impact alignment and contribute to the complaint condition.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: PERIARTICULAR AIMING ARM FOR 4.5MM LCP PROX TIBIA PL-RT
• Type of Device: GUIDE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5095519
• MDR Text Key: 26605792
• Report Number: 3003875359-2015-10414
• Device Sequence Number: 1
• Product Code: FZX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Followup
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.120.001
• Device Lot Number: 1810704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 005112
• Patient Sequence Number: 1