MAUDE Adverse Event Report: SYNTHES HAGENDORF INSERTER-EXTRACTOR FOR TI TIBIAL & HUMERAL NAILS

Catalog Number 356.490

Device Problem Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Occurred post-operatively; there was no longer any patient involvement.Device is an instrument and is not implanted/explanted.(b)(6).Manufacturing location: (b)(4).Manufacturing date: july 22, 2016.No non-conformance reports 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.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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that dismantling of both the inserter/extractor for solid/cannulated tibial nail (utn/ctn) and the connection screw for unreamed humeral nail (uhn) was not possible postoperatively.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product investigation has been completed for part# 356.490, lot# 9613764.The returned device was analyzed for conformances to print specifications, as well as the device history records were researched.No abnormal findings were identified.The screw connection of the device was found completely jammed.The connection could not be solved with great force.Based on these results, we can exclude manufacturing fault.We can only assume that the occurrence may have been due to insufficient connection with this instrument.If the connection is not tight, the forces while hammering may cause the damage of the threaded connection.Since we are not aware of exact circumstances during the surgery, we suppose that a mechanical overloading situation must have led to the occurrence.Complaint is confirmed due to evidence that this instrument jammed, but considered not valid from manufacturing standpoint as there is no evidence of manufacturing related issues.No indication for product related issue was found.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: INSERTER-EXTRACTOR FOR TI TIBIAL & HUMERAL NAILS
• Type of Device: EXTRACTOR
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6165883
• MDR Text Key: 62388922
• Report Number: 3003875359-2016-10645
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 07611819023529
• UDI-Public: (01)07611819023529(10)9613764
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/17/2016

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: 356.490
• Device Lot Number: 9613764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2016
• Initial Date FDA Received: 12/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2016
• 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