MAUDE Adverse Event Report: SYNTHES GMBH 12.0MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR

Catalog Number 352.250S

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

Additional device product codes: hrx.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Initial reporter facility name: (b)(6) hospital.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the surgery for the non-union with the ria drive shaft and ria reamer head.This was a case of bone grafting to the ipsilateral distal tibia using ria for the femur.For a patient with 10.5 mm diameter femur and medullary cavity, a 12 mm reamer head was opened.There was an attempt to insert the reamer head through the tube assembly, through the drive shaft 520 mm, and was initially difficult to insert.After 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.The same issue occurred; the reamer head came off at the same point.When reattaching the reamer head, it was confirmed that the hook part of the reamer head was damaged.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.The patient was reported as stable.Concomitant devices reported: ria tube assembly, for ria drive shaft (part number 314.746, lot unknown, quantity 1).Ria driveshaft l520 (part number 314.743, lot h427158, quantity 1).This report involves one (1) 12.0mm reamer head-sterile for reamer/irrigator/aspirator.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Investigation summary: the product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the received device.Visual analysis of the returned sample revealed that three of the four tabs at the proximal end of the reamer head device were broken off.The broken tabs 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 tabs 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 of the reamer head tabs would contribute to the alleged device interaction and functional issues.While no definitive root cause could be determined, it is possible that the observed 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: 12.0mm reamer head ria.Device history lot: part#: 352.250, synthes lot#: h544000, supplier lot#: na, release to warehouse date: mar 6, 2018, manufactured by synthes monument, no ncr's were generated during production.Device history review: 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.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: 12.0MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11307245
• MDR Text Key: 231150496
• Report Number: 8030965-2021-00909
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819915893
• UDI-Public: (01)07611819915893
• Combination Product (y/n): N
• PMA/PMN Number: K111437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.250S
• Device Lot Number: H544000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Date Manufacturer Received: 02/23/2021
• Patient Sequence Number: 1
• Treatment: RIA DRIVESHAFT L520.; RIA TUBEASSEMBLY MIN-L 520 F/314.743.; RIA DRIVESHAFT L520.; RIA TUBEASSEMBLY MIN-L 520 F/314.743.