MAUDE Adverse Event Report: SYNTHES GMBH DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA; REAMER

Catalog Number 314.743

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

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

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

Part # 314.743.Synthes lot # h427158.Supplier lot # h427158.Release to warehouse date: (b)(4) 2018.Supplier: (b)(4).No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The product was returned to us customer quality (cq) for evaluation.The us cq team conducted a visual inspection of the received device.Visual analysis of the returned sample revealed that the distal tip of the drive shaft component was broken off.Some of the broken pieces were received at us cq.The functional test cannot be performed as the received sample was broken and furthermore, all mating devices were not returned for the analysis.The dimensional analysis was not performed due to the post-manufacturing damage.The broken condition of the distal tip (drive feature) was consistent with a random component failure that may have been caused by exposure to unintended/overt forces.It should be noted that as part of synthes trauma¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed broken condition would contribute to the alleged device interaction and functional issues.While no definitive root cause could be determined, it is possible that the alleged broken condition may be occurred due to a random component failure that may have been caused by exposure to unintended/overt forces.There was no indication that a design or manufacturing issue contributed to the complaint.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 document/specification review: the following drawing reflecting the current and manufactured revision was reviewed: drive shaft assembly ria 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 a non-union.A bone graft to the ipsilateral distal tibia was performed using the ria for the femur.The patient had a 10.5 mm diameter femur and medullary cavity so a 12 mm reamer head was use.The reamer head was inserted through the tube assembly through the drive shaft 520 mm, initially it was difficult to insert, but still fit.After the retraction, the surgeon inserted the tube assembly by reaming through the reaming rod.The reamer head came off in the intrathecal space when shaving the isthmus, it was removed once and reattached but occurred a second time.When reattaching the reamer head, it was confirmed that the hook part of the reamer head was damaged.At that time, sufficient bone collection was completed and the patient was transferred to bone transplantation.After surgery, it was found that the tip of the drive shaft was also damaged.The surgery was completed successfully without any surgical delay.Concomitant device: ria tube assembly, for ria drive shaft (part:314.746; lot# unknown; quantity: 1) this report is for one (1) drive shaft-minimum 520mm length-for use with ria.This is report 1 of 2 for pc (b)(4).

• Brand Name: DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11544781
• MDR Text Key: 245788484
• Report Number: 8030965-2021-02193
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819739208
• UDI-Public: 07611819739208
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K013527
• 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: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 314.743
• Device Lot Number: H427158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2018
• 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