MAUDE Adverse Event Report: SYNTHES GMBH DISTRACTOR TIP FOR MATRIX DETACHABLE HOLDING SLEEVE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.632.083
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in the (b)(6) as follows: it was reported that on (b)(6) 2021, during a procedure the distractor tip sheared off.There was no surgical delay.There was no impact to the patient.The procedure was completed successfully.This report involves one (1) distractor tip for matrix detachable holding sleeve.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.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.

• Brand Name: DISTRACTOR TIP FOR MATRIX DETACHABLE HOLDING SLEEVE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13113611
• Report Number: 8030965-2021-10543
• Device Sequence Number: 4589220
• Product Code: LXH
• UDI-Device Identifier: 10705034719252
• UDI-Public: (01)10705034719252
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Other
• 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 Model Number: 03.632.083
• Device Catalogue Number: 03.632.083
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/29/2021
• 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: IN-SITU BENDER F/R Ø5.5 R
• Patient Sex: Unknown