MAUDE Adverse Event Report: SYNTHES USA; EXTRACTOR

Device Problem Fitting Problem (2183)

Patient Problems Tissue Damage (2104); Sedation (2368)

Event Date 12/09/2014

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during a removal operation of japanese proximal femoral nail antirotation (pfna), the extraction screw in question would not connect to the compression blade.The surgeon expanded the affected part by removing the callus and the soft tissue to see the part, and then found that the hexagonal part to unlock the blade was completely worn out.The operation finished with a two hour surgical delay, leaving those implants in the patient's bone.This report is for one unknown extraction screw.This report is 3 of 3 for (b)(4).

Manufacturer Narrative

This report is for one unknown pfna extraction screw.Date of original implant is unknown.Implant was not fully explanted.Parts remain in the patient.Per facility, the complainant part will not be returned to the manufacturer for review/investigation.Device is not distributed in the united states, but is similar to a device marketed in the usa.Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number was provided.Device 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.

Manufacturer Narrative

Date returned to manufacturer.Expiry date:1st february 2019; expiry date:1st august 2022.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Manufacturing date:19th february 2009.Unsure which part/lot # is associated with the unknown screw.Device history records was conducted.The report indicates that the: 459.400vs lot.2458699.Manufacturing location:(b)(4), manufacturing date:19th february 2009, expiry date:1st february 2019.No ncrs were generated during production.Review of the device history record (s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Manufacturing date:28th september 2012 unsure which part/lot # is associated with the unknown screw.Device history records was conducted.The report indicates that the: 459.380vs lot.5918658, 459.380vs lot.5918658, manufacturing location:(b)(4), manufacturing date:28th september 2012.Expiry date:1st august 2022, no ncrs were generated during production.Review of the device history record (s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Dhr review - in the first follow up report, the dhr was inadvertently submitted for two locking bolts, however the part is for an extraction screw.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.

Manufacturer Narrative

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.

• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4398361
• MDR Text Key: 5309667
• Report Number: 2520274-2015-10149
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR