MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER RASP SIZE 1 37.5/44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	0580-3744-1
Medical Device Problem Codes	Break (1069); Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
When using the femoral bark, the instruments broke inside the patient, making the withdrawal process difficult.It was necessary to use instruments from another supplier to drill the broken instruments and to remove them, increasing the time of surgery in 2 hours.
Additional Manufacturer Narrative
An event regarding crack/fracture involving an exeter rasp was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: not performed as no medical records were received for review with a clinical consultant.Product history review: not performed as the lot information provided was invalid.Complaint history review: not performed as the lot information provided was invalid.Conclusions: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as product lot code, product return, images of the device taken when the alleged event was identified as well as operative notes are required to complete the investigation for confirming the event and determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
When using the femoral bark, the instruments broke inside the patient, making the withdrawal process difficult.It was necessary to use instruments from another supplier to drill the broken instruments and to remove them, increasing the time of surgery in 2 hours.

• Brand Name: EXETER RASP SIZE 1 37.5/44MM
• 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: 8104443
• Report Number: 0002249697-2018-03821
• Device Sequence Number: 1599420
• Product Code: LPH
• UDI-Device Identifier: 07613327207743
• UDI-Public: 07613327207743
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0580-3744-1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 01/09/2019
• 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; Required Intervention