MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM FLEXIBLE SHAFT; REAMER

Catalog Number 352.040

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

Product code: 352.040 lot: 8592794 manufacturing site: (b)(4).Release to warehouse date: september 13, 2013 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The product was returned to us customer quality (cq) for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that synream flexshaft tip of the flexible shaft is bent and deformed.The dimensional inspection was not performed due to post manufacturing damage.The bent and deformed condition of the tip of the shaft was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed, as the observed deformed and bent condition of the synream flexshaft.Although no definitive root-cause can be determined, it¿s possible the device experienced unintended forces, there is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.The following drawing reflecting the current and manufactured revisions was reviewed: pipe.Flex.Welle d7.0mm.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2021, the patient underwent surgery for tibial shaft.When the surgeon performed reaming of the medullary cavity, the reamer head came off.This was confirmed by using the image intensifier.The surgeon removed reaming rod, reamer head, flexible shaft all together.No pieces remained in the patient.The tip of the flexible shaft was found to be damaged.Procedure was completed successfully.Patient was stable.Upon manufacturer investigation, it was determined that the device was bent and deformed.This report is for a 5.0mm flexible shaft.This is report 1 of 1 for (b)(4).

• Brand Name: 5.0MM FLEXIBLE SHAFT
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12180560
• MDR Text Key: 261937157
• Report Number: 8030965-2021-05821
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.040
• Device Lot Number: 8592794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2013
• 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
• Treatment: UNK - REAMERS; UNK - REAMERS: REAMER HEAD; UNK - REAMING RODS
• Patient Age: 29 YR