MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL IMPACTOR/POSTIONER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	2101-0200
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
After inspection after dishwasher it was discovered that the thread is "broken.".
Additional Manufacturer Narrative
An event regarding thread damage involving a cutting edge impactor was reported.Review of the product history records indicate that devices were manufactured and accepted into final stock with no reported relevant discrepancies.There have been no other events for the reported lot.It was reported that the thread was broken.Visual inspection of the returned device noted that the device was returned in used condition.Scratch marks are observed on the surface of the device.The threads are observed to be damaged.Examination of the returned device by a material analysis engineer indicated that damage observed on threads consistent with cross threading and off axis loading.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The device was discovered during inspection after washing.There was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance; 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
After inspection after dishwasher it was discovered that the thread is "broken.".
Event or Problem Description
After inspection after dishwasher it was discovered that the thread is "broken.".

• Brand Name: UNIVERSAL IMPACTOR/POSTIONER
• 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: 7502111
• Report Number: 0002249697-2018-01390
• Device Sequence Number: 194224
• Product Code: LPH
• UDI-Device Identifier: 07613327211511
• UDI-Public: 07613327211511
• Combination Product (Y/N): N
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2018

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: 2101-0200
• Device Lot Number: 141629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 06/15/2018; 06/22/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 06/15/2018; 07/19/2018
• 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