MAUDE Adverse Event Report: SYNTHES GMBH DISTRACTOR TIP FOR MATRIX DETACHABLE HOLDING SLEEVE

Model Number	03.632.083
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the received images.The images were reviewed, and the complaint condition is confirmed.The threaded tip of the distractor appears to be broken in the images.A definitive assignable root cause could not be determined based on the provided information.No valid lot number was provided or found in the photos, therefore no device history record (dhr) review was completed.The dhr review will be revisited if a valid lot number is provided or the physical device is received.As the device was not returned, an as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.During the investigation, no product design issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.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 or Problem Description
Device report from(b)(6) reports an event as follows: it was reported that during set-up for a procedure on (b)(6), 2021, it was noted that the shaft of the first device was broken/snapped off, so it was left aside.A second device from the same kit was inspected to use, but it was also noted that the spring on the shaft was coming off.This was deemed unsafe to use on patient.The same like device from another kit was used to proceed with the case.Case was completed with no patient consequence.This report is for a distractor tip for matrix detachable holding sleeve.This is report 1 of 3 (b)(4).

• Brand Name: DISTRACTOR TIP FOR MATRIX DETACHABLE HOLDING SLEEVE
• Common Device Name: DISTRACTOR TIP FOR MATRIX DETACHABLE HOLDING SLEEVE
• 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: 12983644
• Report Number: 8030965-2021-10152
• Device Sequence Number: 20260612
• Product Code: LXH
• UDI-Device Identifier: 10705034719252
• UDI-Public: (01)10705034719252
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 11/15/2021

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
• Device Model Number: 03.632.083
• Device Catalogue Number: 03.632.083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: RETAIN-SLEEVE DETACHABLE F/MATRIX 5.5; RETAIN-SLEEVE DETACHABLE F/MATRIX 5.5
• Patient Age: 69 YR
• Patient Sex: Female