MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HAMMER 700 GRAMS; HAMMER, SURGICAL

Model Number	399.43
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the assessment, it was concluded that the received device was not owned or released by dps.The complaint was communicated to brand protection team.The complaint device was received and evaluated by customer quality in west chester.A visual evaluation was performed and it was determined that, although product code 399.43 was etched on the handle, the hammer was not a device manufactured or distributed by depuy synthes (dps).All revisions of the drawing released by dps were reviewed and the design is made of five (5) components (a head, shaft, handle and 2 dowel pins).The handle of the hammer on all of the design revisions of part number 399.43 consists of a stainless steel shaft that is inserted into the base of the head and a phenolic handle and then pinned in place.The head on all designs revisions of part number 399.43 is a stainless steel cylinder with hexagonal ends.The device that was received had two components; an aluminum handle and a steel head.The handle on the returned device is a single piece of machined aluminum with flats machined on the front and back and semi-circular grooves machined into each side.The head appears to be stainless steel and is a cylinder with circular bases.The design of all components on all released revisions of the drawing are totally different from the received device.Therefore, it was concluded that the returned device was not manufactured or distributed by dps.The complaint was communicated to brand protection team.Device was used for treatment, not diagnosis.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
It was reported that on an unknown date, a hammer was ordered but a different hammer was delivered.The head part may be the same but the handle is different.There was no patient involvement.This report involves one (1) hammer 700 grams.This is report 1 of 1 for (b)(4).

• Brand Name: HAMMER 700 GRAMS
• Common Device Name: HAMMER, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12648230
• Report Number: 2939274-2021-06149
• Device Sequence Number: 1713025
• Product Code: FZY
• UDI-Device Identifier: 10886982202819
• UDI-Public: (01)10886982202819
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/19/2021

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 Model Number: 399.43
• Device Catalogue Number: 399.43
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1