MAUDE Adverse Event Report: SYNTHES SELZACH REAMER Ø11 F/PFNA BLADE

Catalog Number 356.821

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information is not available for reporting.It is unknown when this device was broken.It was discovered to be broken on (b)(6) 2016.(b)(4).Device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.(b)(6).510(k): device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.The date of manufacture is unknown.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 (b)(4) reported an event the (b)(6) as follows: it was reported that during the surgery on (b)(6) 2016 while using the proximal femoral nailing set, the reamer broke.The surgeon was able to retrieve a large reamer fragment but a small fragment still remains in the patient outside of the bone.Another set was opened and it was noticed that the tip of the reamer in the second set was broken too.It is unknown if the second reamer broke when it was last used or whether it broke during the cleaning process.Additional information is not available.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

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 patient outcome was not affected.The surgery was prolonged approximately fifteen to twenty (15-20) minutes.They used time for an additional x-ray to locate the missing pieces of the broken off reamer.

Manufacturer Narrative

Device history records review was completed for part# 356.821, lot # u112364.Manufacturing location: (b)(4), manufacturing date: nov 04, 2009.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Manufacturing investigation was completed for part# 356.821, lot # u112364.The received drill bit is in a very used condition, there are strong stress marks at the shaft visible, the coupling piece has strong wear marks from often use, the cutting edges are completely blunt and have nicks all over.The manufacturing documents were reviewed and no complaint related issues were found.The drill bit with lot u112364 was manufactured in november 2009 according to the specification.The relevant dimensions were checked and no deviation was found.Based on these findings we exclude any manufacturing related issue.There was no information provided about when or how this breakage occurred.Based on the blunt condition of the cutting edges we can only assume that an excessive metallic contact or the use of a blunt instrument did lead to a mechanical overload and finally the breakage.In general it is mentioned in important information leaflet regarding reprocessing: end of life of a device is normally determined by wear and damage due to use.Evidence of damage and wear on a device may include but is not limited to corrosion (i.E.Rust, pitting), discoloration, excessive scratches, flaking, wear and cracks.Improperly functioning devices, devices with unrecognizable markings, missing or removed (buffed off) part numbers, damaged and excessively worn devices should not be used.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: REAMER Ø11 F/PFNA BLADE
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach PA CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6071689
• MDR Text Key: 58935885
• Report Number: 2520274-2016-15158
• Device Sequence Number: 1
• Product Code: HTO
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 356.821
• Device Lot Number: U112364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2009
• 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