MAUDE Adverse Event Report: AMR A0L75, MALLEABLE SPINE ASSY 7; DXC

Model Number	A0L75
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the incident device and the product has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of the investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.There is no report of serious injury or death associated with this event.
Event or Problem Description
Procedure performed: n/a- "we opened a malleable jaw assembly a0l75.The surgeon bent it to adjust the angle before applying it, and a small plastic ring broke off.Luckily we believe we found all the pieces.The ring was located at the join of the malleable shaft to the jaw assembly.The clamp was unable to be used after this as it was completely malleable.Couldn't make it rigid." patient status: "fine".
Additional Manufacturer Narrative
Evaluation summary: the event device was returned for evaluation.Upon visual inspection, product damage as described by the customer was confirmed.Engineering noted the epoxy used to bond the spine and jaw assembly had separated.A strong external force likely caused the separation.A review of the manufacturing records indicated this lot passed all manufacturing and quality inspections.The root cause could not be determined.A review of the complaint records history since january 2013 indicated that this was the first event of this kind.Although the root cause of the customer's experience could not be determined, applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.

• Brand Name: A0L75, MALLEABLE SPINE ASSY 7
• Common Device Name: DXC
• Manufacturer (Section D): AMR; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5842112
• Report Number: 2027111-2016-00554
• Device Sequence Number: 19026265
• Product Code: DXC
• UDI-Device Identifier: 00607915110550
• UDI-Public: (01)00607915110550(17)180602(30)01(10)1198483
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K002915
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2016

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: Other
• Device Expiration Date: 06/02/2018
• Device Model Number: A0L75
• Device Catalogue Number: 100707301
• Device Lot Number: 1198483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/02/2016
• Supplement Report FDA Received Date: 12/28/2016
• Patient Sequence Number: 1