MAUDE Adverse Event Report: SYNTHES SELZACH REAMER Ø4.5/6.5 L450 F/HIP SCR F/EXPERT

Catalog Number 03.010.368

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

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

Event Date 10/02/2017

Event Type  malfunction  

Manufacturer Narrative

Patient identifier, date of birth, and weight not available for reporting.Device is an instrument and is not implanted/explanted.Device is not distributed in the united states, but is similar to device marketed in the usa.A review of the device history records has been requested.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 a procedure to repair a femoral diaphyseal fracture on (b)(6) 2017, while using the reamer, the tip of the reamer broke off.Surgeon removed the nail and removed the fragments generated.Surgeon stated the reamer passed through the nail without difficulty but the tip broke around the femoral neck.It was noted that the reamer did not touch the nail.Surgery was completed successfully with a delay of approximately 60 minutes and no harm to patient.Patient status reported as okay.Concomitant devices reported: nail (part number unknown, lot number unknown, quantity 1).This report is for one (1) reamer.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A manufacturing investigation was conducted/performed.The report indicates that the: 1x article 03.010.368 with lot u145207 / reamer ø4.5/6.5 l450 f/hip scr f/expert received and forwarded to us supplier for investigation: as received condition of device: the device was received with the drill step fracturing at the transition to the main drill body.Investigation summary: supplier: (b)(4).Per the attached supplier product investigation: one part of product code 03.010.368 from lot u145207 and the review was completed on 12/21/17 this lot was manufactured in december of 2011.The dhr was reviewed and it was found that the job was process according the production plan with conforming inspection results.Due to the nature of failure, the drill step fracturing at the transition to the main drill body, the web, transition angle, step diameter, and drill body diameter were all measured.Supplier investigation¿.All features were found to be conforming.The exact root cause could not be found.It is likely that an overloading situation led to this reamer breakage.No manufacturing related issue was identified and/or confirmed, therefore review to the specific prm and prm line is not applicable.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.

Manufacturer Narrative

A device history record (dhr) review was performed for part # 03.010.368, lot # u145207: manufacturing location: (b)(4), supplier: external supplier (b)(4), manufacturing date: 13.Dec.2011: 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.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 Ø4.5/6.5 L450 F/HIP SCR F/EXPERT
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach 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: 6977313
• MDR Text Key: 91099099
• Report Number: 3000270450-2017-10377
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819326958
• UDI-Public: (01)07611819326958(10)U145207
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.368
• Device Lot Number: U145207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2011
• 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: 86 YR