MAUDE Adverse Event Report: SYNTHES GMBH SYNREAM REAMING ROD 2.5 SHORT L950; REAMER

Catalog Number 352.032

Device Problem Material Deformation (2976)

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

Event Date 07/02/2021

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.Device is not distributed in the united states, but is similar to device marketed in the usa.The lot number is unknown, and therefore, dhr could not be completed.If the lot number can be confirmed, the dhr will be revisited.A manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure no manufacturing record evaluation is required.Visual inspection: the synream reaming rod ø2.5 short l950 (p/n: 352.032, lot #: unk) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the device was bent and broken.The broken piece was returned.No other issues were observed with the returned device.Device failure/defect identified? yes.Dimensional inspection: the thickness of the rod was measured to be within the specification.Document/specification review since the exact manufactured date of the device was not identified, the current revision of drawings was reviewed - reaming rod / bohrdorn ø2.5mm complaint confirmed? yes, the device received was bent, investigation conclusion: the complaint condition was confirmed as the device was bent and broken.No definitive root cause can be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.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 the reaming rod was bent and the drill did not pass.The surgeon broke the device but was able to use it to complete the procedure.The procedure was successfully completed with a twenty (20) minute delay and no medical intervention needed.This report involves one (1) synream reaming rod ø2.5 short l950.This is report 2 of 2 for (b)(4).

• Brand Name: SYNREAM REAMING ROD 2.5 SHORT L950
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12641256
• MDR Text Key: 276903529
• Report Number: 8030965-2021-08740
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819287518
• UDI-Public: (01)07611819287518
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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