MAUDE Adverse Event Report: SYNTHES GMBH 8.5MM MEDULLARY REAMER HEAD

Catalog Number	352.085
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint(b)(4) 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.H11 additional narrative: d9: the product was returned to depuy synthes for evaluation.E3: reporter is a j&j sales representative.Investigation summary broken tip of reduction forceps the 8.5 reamers x 3 need to be changed as they aren't sharp enough anymore h3, h4, h6: visual inspection of the returned device found that one ratcheted jaw of the device was broken.The product was returned to depuy synthes for evaluation.Visual analysis of the device found blunting of cutting edges.It is not unreasonable that the condition identified in visual analysis would contribute to a dull condition.Therefore we are able to confirm dullness with damage observed, as this kind of evidence indicates repeated use of the device.The lifecycle requirements of the device are event related and depend on the use in clinical practice, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of synream reamer head ø8.5 would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.The drawings reflecting the current and manufactured revisions were reviewed.Device history lot part:352.085 lot no:f-18979 release to warehouse date: 21 oct 2015 manufacturing site: werk selzach supplier: (b)(4) a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 or Problem Description
It was reported that broken tips of reduction forceps were discovered.The 8.5 reamers x 3 need to be changed as they are not longer sharp.It is unknown if patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing or if the patient required revision surgery or hardware removal.This report is for one (1) 8.5mm medullary reamer head this is report 4 of 4 for complaint (b)(4).

• Brand Name: 8.5MM MEDULLARY REAMER HEAD
• Common Device Name: 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19581475
• Report Number: 8030965-2024-07749
• Device Sequence Number: 16960540
• Product Code: HTO
• UDI-Device Identifier: 07611819243699
• UDI-Public: (01)07611819243699
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 352.085
• Device Lot Number: F-18979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RED FORCEPS SERRATED JAW-RATCHET 144; SYNREAM REAMER HEAD Ø8.5; SYNREAM REAMER HEAD Ø8.5
• Patient Sex: Unknown