MAUDE Adverse Event Report: DEPUY SPINE INC W-H CHISEL 1/2 LG 15 LONG; CHISEL, SURGICAL, MANUAL

Model Number	202953
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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
It was reported bad instruments shipped.Chipped blades.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 --> unknown, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, is the patient part of a clinical study --> unknown.
Additional Manufacturer Narrative
(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.Visual examination of the returned device found no damage to be observed to the chisel beyond some deformity at its very tip.The metal is crumpled, and small sections may have fragmented off.The amount of damage is small, and difficult to determine the precise type of damage.However, it does appear that a certain amount of material may be missing from the tip as opposed to simply being impacted.A standard fracture analysis is difficult to perform due to the scope of the damage, but this may be a static overload failure due to the high forces placed on the instrument during use and the raw edge of the damage.It has been noted that the certificate of conformance was provided, confirming that the instrument passed testing associated with hardness standards.The crumpling and fracture to the tip of the chisel may occur due to wear and tear over the course of many uses and high striking forces it experiences.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.The root cause of the damage to the chisel¿s tip cannot be determined from the sample and the information provided.A potential root cause may be the higher than anticipated impact forces experienced during use, resulting in material deformation and potential static overload fracture.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: W-H CHISEL 1/2 LG 15 LONG
• Common Device Name: CHISEL, SURGICAL, MANUAL
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8375007
• Report Number: 1526439-2019-51392
• Device Sequence Number: 1098599
• Product Code: FZO
• UDI-Device Identifier: 10705034000893
• UDI-Public: (01)10705034000893
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2019

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: 202953
• Device Catalogue Number: 202953
• Device Lot Number: MB241116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 03/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1