MAUDE Adverse Event Report: SYNTHES GMBH SYNREAM REAMER HEAD Ø12

Catalog Number	352.120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery at the time of milling with the head of milling synream, the synream broke.A prompt solution is given removing the fragments of this and passing to the doctor.A new synream head was used for milling, thus achieving successful completion of the surgery, without discomfort of the specialist, without affecting the patient and without alterations in the surgical times.
Additional Manufacturer Narrative
Product complaint #(b)(4).J&j medtech is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which j&j medtech has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, j&j medtech or its employees that the report constitutes an admission that the device, j&j medtech, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H3, h6: the device lot number is unknown, therefore a¿device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.The product was not returned to medtech orthopaedics, however photos were provided for review.The photo investigation revealed that '(352.120,synream reamer head ø12) had broken.The observed condition of the device was consist with a random component failure that may have been caused by exposure to unintended force.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was (confirmed) as the observed condition of the (synream reamer head ø12) would contribute to the complained device issue.Based on the investigation findings, component failure and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of medtech orthopaedics 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SYNREAM REAMER HEAD Ø12
• Common Device Name: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 21976952
• Report Number: 8030965-2025-04614
• Device Sequence Number: 13058460
• Product Code: HTO
• UDI-Device Identifier: 10886982194244
• UDI-Public: (01)10886982194244
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• 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: 352.120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown