MAUDE Adverse Event Report: SYNTHES HAGENDORF AIMING ARM FOR 3.5MM VA-LCP PROXIMAL TIBIA PLATE; PLATE, FIXATION, BONE

Catalog Number 03.127.009

Device Problem Bent (1059)

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

Event Date 05/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Manufacturing site: (b)(4).Manufacturing date: july 17, 2012.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 while using the variable angle periarticular plating system (va-lcp) proximal tibia plates with the aiming instrument it was observed that distally they were not lining up very well.The surgeon used a wrench and pliers to make them line up better.The aiming arm may have bent during the procedure.The surgery was completed successfully.Afterward the aiming arm was compared to another one and it was indeed bent.Concomitant devices reported: insertion handle (part 03.127.007, lot 7992696, quantity 1).This is report 1 of 1 for com- (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

Although there were no product defect findings during the investigation of the returned product (see below for details), the determination will remain "reportable" based upon the customer's original report.No change to reportability determination.Product investigation summary: one (1) aiming arm for 3.5mm va-lcp proximal tibia plates (part: 03.127.009 / lot: 7972203) was received for evaluation.The returned instrument was examined and the complaint condition was unable to be confirmed as no visible deformations and/or tool marks were noted.As the complaint was unable to be replicated, and no defects or deficiencies were identified, no further investigation is necessary.The complaint is unconfirmed.Part 03.127.007 with lot 7992696 was also returned as a concomitant device without an alleged complaint condition.Upon visual inspection, there is no evidence that this device contributed to the complaint condition.Therefore, no additional investigation will be performed on this device.The returned instrument is part of depuy synthes variable angle periarticular plating system.The instrument is designed to aid in the insertion and fixation of 3.5 variable angle (va) lcp proximal tibia plates.This information is provided by the 3.5mm va-lcp proximal tibia plate system technique guide and the va-lcp proximal tibial plate 3.5 technique guide.The root cause of the complaint condition is unknown.A possible cause could be surgical technique, as it was stated in the complaint description that the surgeon used a wrench and pliers to make them line up better with the proximal tibia plate.Device 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: AIMING ARM FOR 3.5MM VA-LCP PROXIMAL TIBIA PLATE
• Type of Device: PLATE, FIXATION, BONE
• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5717996
• MDR Text Key: 47209867
• Report Number: 3003875359-2016-10348
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK120689
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2016

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: 03.127.009
• Device Lot Number: 7972203
• Other Device ID Number: (01)10886982075093(10)7972203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/26/2016
• Initial Date FDA Received: 06/10/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/24/2016; 07/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2012
• 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: 67 YR