MAUDE Adverse Event Report: DEPUY SPINE INC EXP 5.5 DEROTATION MODULAR CLA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	279788965
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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
Product just broke without any reason.Did the event occur during sterile processing? unknown, did the event occur during field inspection? unknown, did the event occur during internal service activities such as calibration? unknown, patient status/ outcome / consequences: no, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? there was no outcome on the patient, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study: unknown.This complaint involves one (1) device.
Additional Manufacturer Narrative
Product complaint # (b)(4).Device manufacture date: additional information.

• Brand Name: EXP 5.5 DEROTATION MODULAR CLA
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9174740
• Report Number: 1526439-2019-52233
• Device Sequence Number: 2775309
• Product Code: LXH
• UDI-Device Identifier: 10705034203386
• UDI-Public: (01)10705034203386
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2019

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: 279788965
• Device Catalogue Number: 279788965
• Device Lot Number: NW147562
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1