MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 4 ACCOLADE II BROACH; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	1020-5204
Medical Device Problem Codes	Material Deformation (2976); Scratched Material (3020)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Company representative reported that during the use of the calcar planner on the broach, metallic fragments were produced and then were manually removed from the surgical site.
Additional Manufacturer Narrative
An event regarding damage involving an accolade broach was reported.The event was not confirmed.Device evaluation and results: the device was returned in used condition.Visual inspection of the device noted multiple scratches, indents, abrasions throughout the device.Review of the returned device with a material analysis engineer indicated "damage observed consistent with in-service use." medical records received and evaluation: not performed as no medical records were provided.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced.Conclusions: the event could not be confirmed as the reported incident is an isolated event and cannot be duplicated in vivo.Visual inspection of the device noted multiple scratches, indents, abrasions throughout the device.Review of the returned device with a material analysis engineer indicated that the damage observed was consistent with in-service use.No further investigation is possible at this time.If the additional information will be received, this investigation will be reopened and re-evaluated.
Event or Problem Description
Company representative reported that during the use of the calcar planner on the broach, metallic fragments were produced and then were manually removed from the surgical site.

• Brand Name: SIZE 4 ACCOLADE II BROACH
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6652457
• Report Number: 0002249697-2017-01931
• Device Sequence Number: 13740637
• Product Code: LPH
• UDI-Device Identifier: 07613327252620
• UDI-Public: 07613327252620
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K153345
• 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): 09/27/2017

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: Health Professional
• Device Catalogue Number: 1020-5204
• Device Lot Number: B7NDJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Initial Date Received by Manufacturer: 05/22/2017
• Supplement Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 06/19/2017
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Weight: 73