MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE RIGID ARM ATTACHMENT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	288210014
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A follow up report will be filed upon completion of the investigation.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
Notified by (b)(6).A complaint was called into customer service for this event.It involved parts from two (b)(6) kits.So we pulled the 288210014 ¿ rigid arm attachment ¿ from pipeb # 17 and we pulled the 292900610 ¿ spot table clamp - from splrab # 60.The 288210014 feels a little sharp around the edge and the 292900610 ¿ is missing the washer.
Additional Manufacturer Narrative
The rigid arm was returned for evaluation.Visual inspection identified cosmetic scratches and signs of wear.Initially this complaint was identified as a reportable malfunction.However, based on device review at intake and during the investigation, this is a non-reportable event.There was no patient involvement.The noted damage is highly detectable and would not likely cause or contribute to adverse patient consequences if the issue were to recur.Review of the device history record identified no issues during the manufacturing or release of the product that could have contributed to the problem reported by the customer.The product was released accomplishing all quality requirements.A review of the complaint trend analysis was performed and no systemic trend was identified as a result of the analysis.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 have been observed, 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: RIGID ARM ATTACHMENT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6768318
• Report Number: 1526439-2017-10633
• Device Sequence Number: 2064757
• Product Code: LXH
• UDI-Device Identifier: 10705034220710
• UDI-Public: (01)10705034220710
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2017

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: Physician
• Device Model Number: 288210014
• Device Catalogue Number: 288210014
• Device Lot Number: 0405V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2017
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 08/04/2017
• Supplement Report FDA Received Date: 09/12/2017
• Patient Sequence Number: 1