MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SLIDE HAMMER FOR HAMMER GUIDE; HAMMER, SURGICAL

Model Number	357.25
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during reverse logistics audit of returned device at millstone the slide hammer for hammer guide was found broken.No patient involvement.This report is for (1) slide hammer for hammer guide.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
The subject device is received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: a product investigation was conducted.Visual inspection: the complaint device (slide hammer for hammer guide) was returned for investigation.Based in physical examination, complaint was confirmed.It was observed the handle of the device as broken.Also it was noted that during breakage, besides of the two separated parts a chipping occurred resulted in a missing part of the handle which was not returned for examination.Yes, breakage of handle was observed.Dimensional inspection: the complaint relevant condition cannot be measured without the destruction of the device.Therefore, a dimensional inspection was not performed.Complaint confirmed: yes, the complaint was confirmed based on the physical examination.Investigation conclusion: the reported condition of the complaint device (slide hammer for hammer guide) was returned for investigation.Based in physical examination, complaint was confirmed.It was observed the handle of the device as broken.Also it was noted that during breakage, besides of the two separated parts a chipping occurred resulted in a missing part of the handle which was not returned for examination.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/ specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H3, h6: a device history record (dhr) review was conducted: part #: 357.25 , synthes lot #: 4592978 , supplier lot #: n/a , release to warehouse date: 12 may 2003, manufactured by: brandywine, no ncr's generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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.G1; h4.

• Brand Name: SLIDE HAMMER FOR HAMMER GUIDE
• Common Device Name: HAMMER, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12807265
• Report Number: 2939274-2021-06690
• Device Sequence Number: 20211716
• Product Code: FZY
• UDI-Device Identifier: 10886982195944
• UDI-Public: (01)10886982195944
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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 Expiration Date: 05/12/2023
• Device Model Number: 357.25
• Device Catalogue Number: 357.25
• Device Lot Number: 4592978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2003
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown